Data / Medical devices / United States / Smith & Nephew, Inc.
Smith & Nephew, Inc.: FDA-registered device maker in Memphis, TN, United States, 362 510(k) clearances and 1 PMA approval
Smith & Nephew, Inc. is registered with the FDA (registration 1020279) in Memphis, TN, United States. It lists 138 device types. The FDA files 362 510(k) clearances and 1 PMA approval under its listings, the newest dated September 8, 2026. 105 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1020279
- Address
- 1450 Brooks RD., Memphis, TN, United States, 38116
- Owner or operator
- Smith & Nephew, Inc. (1020279)
- Roles
- Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
- First device listed
- February 22, 1978
- Registered through
- 2027
- Brand names listed
- 1.2 RAP-PAC A LATEX FREE, 1.2 RAP-PAC A, 72202796, 1.2 RAP-PAC B LATEX FREE, 1.2 RAP-PAC B, 72202797, 1.2 RAP-PAC C, 1.5 MM TENDON DRILL PIN, 1.5mm Guidewire, 12", 72202189, 1.6MM DRILL & GUIDE DYNOMITE 2 and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 362.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 8, 2026 | K261462 | LANDMARK Total Knee System | MBH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 6, 2026 | K254084 | AETOS Shoulder System - CONCELOC Glenoids | KWS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 29, 2025 | K252416 | AETOS Shoulder System Meta Humeral Prosthesis Size 0 | KWS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 3, 2025 | K252129 | AETOS Shoulder System Stemless Humeral Prosthesis | PKC | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| June 12, 2025 | K243608 | TRIGEN Stable Lock Nut & Washer | JDS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 2, 2025 | K250677 | LEGION Total Knee System | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| March 28, 2025 | K250571 | CATALYSTEM Femoral Stems | LZO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| February 19, 2025 | K241666 | EVOS Pelvic and Acetabular System | HRS | Substantially Equivalent | Smith & Nephew | accessdata.fda.gov |
| December 9, 2024 | K243364 | TRIGEN META-TAN Trochanteric Antegrade Nail | HSB | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| November 20, 2024 | K240716 | AETOS Shoulder System Stemless Humeral Prosthesis | PKC | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 30, 2024 | K242711 | JOURNEY II Unicompartmental Knee System (JOURNEY II UK) | HSX | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 21, 2024 | K240783 | Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems | JDI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 7, 2024 | K242375 | OR3O Dual Mobility System | LPH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| September 20, 2024 | K240061 | TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System | JDS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| September 3, 2024 | K240487 | EVOS Patella Plates | HRS | Substantially Equivalent | Smith & Nephew | accessdata.fda.gov |
| August 22, 2024 | K241804 | TRIGEN INTERTAN 10S Nail System | JDS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| June 27, 2024 | K240381 | CATALYSTEM Femoral Stems | LZO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| May 30, 2024 | K233674 | Freedom Wrist Arthroplasty System | JWJ | Substantially Equivalent | Ascension Orthopedics, Inc. | accessdata.fda.gov |
| March 18, 2024 | K240113 | CORIOGRAPH Knee Pre-Op Plan | PBF | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| March 13, 2024 | K233949 | ACCORD Cable System | JDQ | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 27, 2023 | K232667 | OR3O Dual Mobility Liners | LPH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 19, 2023 | K231448 | TANDEM Hip System | LZY | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| June 7, 2023 | K230572 | AETOS Shoulder System | KWS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| May 30, 2023 | K223762 | Smith & Nephew ACCORD Cable System | HRS | Substantially Equivalent | Smith & Nephew | accessdata.fda.gov |
| May 4, 2023 | K230653 | Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ System, JOURNEY Uni Knee System, Legion Hinge Total Knee System, Legion Total Knee System, ZUK Unicompartmental Knee System, ENGAGE Partial Knee System and Porous Patella and Porous Tibial Baseplates | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| March 30, 2023 | K230555 | Cemented Tibia Baseplate no Taper with JRNY Lock | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 3, 2023 | K220847 | AETOS Shoulder System | KWS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| November 14, 2022 | K210980 | Smith & Nephew Intramedullary Nail Systems | HSB | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 18, 2022 | K213123 | EVOS Wrist Spanning Plate | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| September 29, 2022 | K213126 | Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws | JDO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 25, 2022 | K221792 | Acute QC Strut and Components | OSN | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 18, 2022 | K220959 | OR3O Dual Mobility System | LPH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 26, 2022 | K221939 | Cemented Round Patella with JRNY Pegs | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 1, 2022 | K211176 | Smith & Nephew Hip Systems | LPH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 26, 2022 | K220896 | Legion Inserts with JRNY Lock | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| March 11, 2022 | K213827 | TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst) | KWS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| February 11, 2022 | K213874 | MAVERICK External Fixation System | JDW | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 19, 2022 | K211330 | R3 Large Head Liners | LPH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 1, 2021 | K211221 | Porous Patella and Porous Tibia Baseplate | MBH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| September 16, 2021 | K211512 | VISIONAIRE UK Patient Matched Cutting Guides | HSX | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 17, 2021 | K211671 | Journey II Mid-Level Tibial Inserts | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 29, 2021 | K210953 | SMART Taylor Spatial Frame | KTT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 27, 2021 | K210016 | Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System | HRS | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| July 19, 2021 | K211548 | POLARSTEM Calcar Reamer Guide | LZO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| June 29, 2021 | K210837 | Smith & Nephew Plates and Screws | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 2, 2021 | K210784 | Extended HA Half Pins | JDW | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| March 25, 2021 | K210566 | LEGION Porous CR Narrow Femoral Components | MBH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 27, 2021 | K203405 | EVOS Large Fragment Plating System | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| December 8, 2020 | K201253 | Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other External Fixation | KTT | Substantially Equivalent | Smith & Nephew | accessdata.fda.gov |
| November 16, 2020 | K202762 | Circular Fixation with Balanced Cable Transport | KTT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| November 16, 2020 | K201918 | EVOS Large Fragment Plating System | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 6, 2020 | K201701 | R3 HA Coated Acetabular Shells | MBL | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 22, 2020 | K201527 | EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm) | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| June 29, 2020 | K201507 | Cadence Total Ankle System | HSN | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| June 4, 2020 | K200227 | Journey II XR Knee Instrument | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| March 13, 2020 | K200407 | LEGION Inserts with JRNY Lock | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| February 28, 2020 | K193029 | CONQUEST FN | JDO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| December 2, 2019 | K190588 | Integra TITAN Reverse Shoulder System | PHX | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| November 21, 2019 | K190439 | Engage Partial Knee System | NJD | Substantially Equivalent | Engage Uni, LLC | accessdata.fda.gov |
| October 31, 2019 | K191002 | OR3O Dual Mobility System | LPH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 25, 2019 | K190847 | REDAPT Blade Augments | LPH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| March 11, 2019 | K190253 | EVOS Small Fragment Upper Extremity Plates Line Additions | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| February 11, 2019 | K190085 | Journey II Unicompartmental Knee System | HSX | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| December 18, 2018 | K182878 | Integra Salto Total Ankle System | HSN | Substantially Equivalent | Ascension Orthopedics | accessdata.fda.gov |
| November 19, 2018 | K182535 | R3 Anteverted Liners | MBL | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| November 16, 2018 | K182109 | REDAPT Modular Acetabular Shell | LPH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| November 2, 2018 | K181639 | Panta 2 Arthrodesis Nail System | HSB | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| October 12, 2018 | K181999 | Integra TITAN Reverse Shoulder System | PHX | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| September 24, 2018 | K181366 | REDAPT Porous Acetabular Shell | LPH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 9, 2018 | K181533 | EVOS Wrist Fracture Plating System | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| June 21, 2018 | K173717 | Integra TITAN Reverse Shoulder System | PHX | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| April 24, 2018 | K180277 | Smith & Nephew SURESHOT Distal Targeting System V4.0 Targeter | OLO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| March 5, 2018 | K180334 | LEGION Knee System | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 8, 2018 | K173293 | EVOS Small Fragment Upper Extremity Plates | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| December 22, 2017 | K172785 | CONQUEST FN | JDO | Substantially Equivalent | Smith & Nephew | accessdata.fda.gov |
| November 21, 2017 | K171073 | Smith & Nephew, Inc. REDAPT Augments | LPH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| November 16, 2017 | K173331 | JOURNEY II XR Knee Instruments | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 3, 2017 | K172684 | Smith & Nephew, Inc. ANTHOLOGY AFIT Hip Stem | LPH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 23, 2017 | K172262 | EVOS Small Fragment Plating System | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 14, 2017 | K162153 | Integra® CAPTURE Screw System & Integra® Ti6® Internal Fixation System | HWC | Substantially Equivalent | Ascension Orthopedics | accessdata.fda.gov |
| June 19, 2017 | K162641 | Smith & Nephew, Inc. R3 Constrained Liner | KWZ | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| June 14, 2017 | K170457 | EVOS Small Fragment Lower Extremity Plates | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| May 22, 2017 | K170282 | Smith & Nephew VISIONAIRE Adaptive Guides | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| May 11, 2017 | K170648 | ANTHEM CR Total Knee System | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| May 3, 2017 | K170977 | SURESHOT Distal Targeting System V4.0 Trauma Interface | OLO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| May 1, 2017 | K162303 | REDAPT Sleeved Monolithic Revision Stems | MEH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 28, 2017 | K170280 | Smith & Nephew SURESHOT Distal Targeting System V4.0 | OLO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 24, 2017 | K170887 | EVOS Small Fragment Plating System | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 13, 2017 | K162775 | Legion Cone System | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| December 14, 2016 | K161233 | OXINIUM DH Fermoral Heads | MBL | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| November 23, 2016 | K161264 | TRIGEN Low Profile Bone Screws | HSB | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| November 18, 2016 | K162078 | EVOS Small Fragment Plating System | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| November 17, 2016 | K160923 | REDAPT Anteverted Cemented Liner | JDI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| November 15, 2016 | K161665 | VLP Wrist Fracture System | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 25, 2016 | K161189 | Integra TITAN Reverse Shoulder System | PHX | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| August 11, 2016 | K153452 | Salto XT, Salto Talaris | HSN | Substantially Equivalent | Tornier S.A.S. | accessdata.fda.gov |
| March 17, 2016 | K152686 | CONQUEST FN | JDO | Substantially Equivalent | Smith & Nephew | accessdata.fda.gov |
| December 23, 2015 | K152047 | INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid | KWS | Substantially Equivalent | Ascension Orthopedics | accessdata.fda.gov |
| November 16, 2015 | K150790 | REDAPT Porous Acetabular Shell and Cemented Liner | LPH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| November 12, 2015 | K152976 | VLP Mini-Mod Talus Plates | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| November 19, 2001 | P000057 | ASCENSION MCP | NEG | 14 | December 31, 2025 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI. Newest 100 of 105.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 6, 2026 | 99904 | Not yet classified | Open, Classified | EVOS 3.5MM LATERAL PROXIMAL TIBIA PLATE 6 HOLE LEFT 91MM REF72463106 | Incorrect labeling; 3.5MM Partial Articular Lateral Proximal Tibia Plate 6 hole Left 91MM implant labeled and lasered etched as as 3.5MM Lateral Proximal Tibia Plate 6 hole left 91mm implant | accessdata.fda.gov |
| March 16, 2026 | 98629 | Class II | Ongoing | TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816 | Humeral nail due to a manufacturing error is missing distal holes and if implanted may lead to revision surgery but, if the missing holes are identified before implantation, an equivalent backup can be used, or a bent nail of the same size, which would require additional surgical steps to address soft tissue/bone preparation, which could lead to a surgical d | accessdata.fda.gov |
| March 18, 2025 | 96586 | Class II | Ongoing | META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690 | Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes. | accessdata.fda.gov |
| October 15, 2024 | 95568 | Class II | Ongoing | Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System. | The Bipolar assembly contains an oversized Retainer Ring. | accessdata.fda.gov |
| July 9, 2024 | 95154 | Class II | Ongoing | DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener | Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires due to a packaging error. A complaint was received indicating that a package contained K-WIRE.062X9 2PT DM wires instead of K-WIRE.045X9 2PT DM as described on the product label. | accessdata.fda.gov |
| September 27, 2023 | 93156 | Class II | Ongoing | JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis | The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM. | accessdata.fda.gov |
| July 24, 2023 | 92767 | Class II | Ongoing | TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail | A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT as described on the product label. | accessdata.fda.gov |
| May 2, 2023 | 92286 | Class II | Ongoing | Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part Numbers: a) REF 1-10003-100 (SIZE 1 Right Medial); b) REF 1-10003-110 (SIZE 1 Left Medial); c) REF 1-10003-200 (SIZE 2-Right Medial); d) | Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the state of the art with respect to the risk for revision. | accessdata.fda.gov |
| March 27, 2023 | 91974 | Class II | Ongoing | JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM | A mispack occurred during the manufacturing process, resulting in the box incorrectly containing JOURNEY II UNI Tibia Insert Medical Size 1-2 12MM instead of the JOURNEY II UNI Tibia Insert Medial Size 7-8 8MM. | accessdata.fda.gov |
| June 27, 2022 | 90547 | Class II | Terminated | (1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left, Product #71420166. | The product was mispackaged (swapped). The devices within the inner tray matches the inner tray but does not match the outer box label and the chart sticks. | accessdata.fda.gov |
| January 4, 2022 | 89382 | Class II | Ongoing | INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF ND | The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw | accessdata.fda.gov |
| December 14, 2021 | 89443 | Class II | Ongoing | Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open and arthroscopic surgical procedures Product Number: 72205104 | Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process | accessdata.fda.gov |
| November 1, 2021 | 89031 | Class II | Terminated | smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101 | Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System. | accessdata.fda.gov |
| October 25, 2021 | 88975 | Class II | Ongoing | Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM. Sterile. | The labels on the packages of screws were switched. | accessdata.fda.gov |
| September 20, 2021 | 88773 | Class II | Terminated | 6.5MMX165MM CANNULATED SCREW | The product label incorrectly indicated that the screws are fully threaded, but the screws contained in the package were partially threaded. | accessdata.fda.gov |
| May 19, 2021 | 88010 | Class II | Terminated | LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral Component, A/P 65.5 MM, M/L 73 MM, For Cemented Use Only, ZR-2.5NB,Sterile. Knee prosthesis component. | The device components experienced a manufacturing process error that resulted in surface damage from product handling. | accessdata.fda.gov |
| December 18, 2020 | 87035 | Class II | Terminated | VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product Number: 71271440 - Product Usage: VERSABOND is a medium viscosity bone cement which can be used for hip, knee, and shoulder implant fixation. V | Potential heat and humidity exposure. The affected lot contained an atypical sandy, flaky or grainy consistency when mixing. | accessdata.fda.gov |
| November 2, 2020 | 86927 | Class II | Terminated | Bone fixation nail. TRIGEN INTERTAN - Product Usage: indicated for fractures of the femur including simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long oblique shaft fractures and segmental s | Manufacturing packaging error. | accessdata.fda.gov |
| September 21, 2020 | 86496 | Class II | Terminated | Genesis (GII) - Product Usage: designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collat | The anterior locking detail does not meet its design specifications. | accessdata.fda.gov |
| August 24, 2020 | 86342 | Class II | Terminated | EVOS Screws - Product Usage: is a part of the EVOS MINI plating system, indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and small bone fragments. | Multiple or incorrect expiration dates were provided on the affected designation labels. | accessdata.fda.gov |
| August 3, 2020 | 86187 | Class II | Terminated | Single RIKKI Retractor, Catalog #71934609 - Product Usage: is used during surgery to hold soft tissue away from the surgical site. | The products were improperly heat treated. | accessdata.fda.gov |
| July 16, 2020 | 86068 | Class II | Ongoing | Tibial knee prosthesis | Due to an inconsistency in the raw material process, specific lots may contain units with internal non-homogenous material defects. | accessdata.fda.gov |
| June 29, 2020 | 85946 | Class II | Terminated | PERI-LOC TARGETER 4.5MM DISTAL FEMUR, HANDLE, LEFT, NON-STERILE - Product Usage: used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC plates and screws are indicated for fixation of p | The 4.5MM PeriLoc Targeter right hand part was anodized green and was marked as a left-hand part. | accessdata.fda.gov |
| June 24, 2020 | 85920 | Class II | Terminated | TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out. It provides additional friction to help hold the screws in place. | A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve. | accessdata.fda.gov |
| April 22, 2020 | 85637 | Class II | Ongoing | smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331842 48MM 71331848 50MM 71331850 52MM 71331852 54MM 71331854 56MM 71331856 58MM 71331858 | A manufacturing error resulted in out of specification R3 Acetabular Shells | accessdata.fda.gov |
| February 27, 2020 | 85110 | Class II | Terminated | NAVIO Soft Tissue Protector, included in instrument kits. The NAVIO Tissue Protector is a reusable instrument designed to, when used as instructed, provide the required bone pin spacing for the Navio bone clamps and pote | Potential for the NAVIO Soft Tissue Protector to become stuck or bound to the bone pin intraoperatively when inserting the NAVIO bone pins. | accessdata.fda.gov |
| January 28, 2020 | 85433 | Class II | Terminated | JOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical instrument used during range of motion trialing to assess joint tension and | The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fall out and the device to disassemble. | accessdata.fda.gov |
| December 19, 2019 | 84647 | Class II | Terminated | LEGION PS High Flex XLPE size 5-6 9mm Articular Insert | LEGION PS High Flex XLPE Articular Insert was packaged with an incorrect part | accessdata.fda.gov |
| December 16, 2019 | 84559 | Class II | Ongoing | LEGION AP Cutting Block Size 4, REF 71434409; LEGION AP Cutting Block Size 6, REF 71434411; LEGION AP Cutting Block Size 7, REF 71434412; LEGION AP Cutting Block Size 8, REF 71434413. (Orthopaedic manual surgical instrum | Multiple lots of LEGION AP Femoral Cutting Blocks were manufactured with an oversize green plunger hole and therefore do not meet their design specifications. | accessdata.fda.gov |
| November 11, 2019 | 84325 | Class II | Terminated | smith&nephew PROFIX Mallet, 750 GRAMS, REF 71512452 - Product Usage: The PROFIX Mallet is a reusable surgical instrument used to tap instruments or implants during knee or hip surgery. | There is a a potential failure mode associated with the use of the mallet, wherein the poly tip of the mallet may become loose and/or come off during use. If the potential failure mode occurs, particles generated in the poly thread potentially could enter the surgical field or a delay in surgery could occur if the tip disengages during the use of the mallet. | accessdata.fda.gov |
| October 7, 2019 | 84059 | Class II | Terminated | LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usage: The TRIGEN InterTAN nails are indicated for fractures of the femur including: simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, lo | LAG SCREW 3.2 GUIDE PIN SLEEVE are being recalled due to a manufacturing error. The detent balls in the guide pin sleeve were not drilled to the correct depth, which will cause them to not fully compress. | accessdata.fda.gov |
| February 19, 2019 | 82193 | Class II | Terminated | smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 SIZE, STEM, REF 713552510 | Complaints were received indicating that the outer label incorrectly identified the product as size "1" instead of "-1". The product contained within the package is size "-1" | accessdata.fda.gov |
| January 7, 2019 | 81917 | Class II | Terminated | SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613 | The pin that holds the spring mechanism is not properly mounted. The pin could potentially disassemble. | accessdata.fda.gov |
| December 10, 2018 | 81766 | Class II | Terminated | JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 1-2, REF 74013986 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNEY II XR tibial basepla | Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch | accessdata.fda.gov |
| September 18, 2018 | 81100 | Class II | Terminated | Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION AP Femoral Cutting Block is a reusable surgical instrument used to make bone cuts on the distal femur to prepar | One lot of the Legion AP femoral cutting block, size 6, was manufactured with an oversized spring. | accessdata.fda.gov |
| June 13, 2018 | 80313 | Class II | Ongoing | Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225, 7 | The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) indicate that the first generation JOURNEY BCS Knee System has a revision rate over 1.5 times the primary total knee arthroplasty device class average revision rates reported in those re | accessdata.fda.gov |
| May 11, 2018 | 80126 | Class II | Terminated | Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) Size 56 mm, REF 74123156 | The affected devices are manufactured to the same design specification as products intended for sale and use in the US but do not contain the FDA approved labeling (i.e., IFU and Patient Information Brochure). The affected devices were distributed in the US with the IFU intended for use outside of the US | accessdata.fda.gov |
| May 4, 2018 | 80125 | Class II | Terminated | smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1) | One lot of GENESIS II 13 mm tibial punches are 2 mm smaller than specification. | accessdata.fda.gov |
| May 2, 2018 | 80050 | Class II | Terminated | smith&nephew ANTHOLOGY POROUS HIGH OFFSET STEM, 12/14 TAPER, 7H SIZE, 32 MM x 112 MM, REF 71356107 Hip prosthesis. | Three lots of Anthology HO Porous size 7 stems were manufactured with an undersized taper length. The device taper length was incorrectly manufactured as 0.393mm opposed to 0.442 mm. | accessdata.fda.gov |
| April 9, 2018 | 79874 | Class II | Terminated | smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 71440014 The GENESIS II Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative | A single lot of GENESIS II FEMORAL FIVE DEGREE VALGUS BUSHING due to a laser mark labeling error. The left valgus bushing was incorrectly laser marked as right and vice versa. | accessdata.fda.gov |
| March 30, 2018 | 79875 | Class II | Terminated | smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM, REF 71453185 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent | The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch. | accessdata.fda.gov |
| March 7, 2018 | 79515 | Class II | Terminated | D-RAD Self-Tapping Locking Screw intended for the fixation of fractures involving the distal radius. smith&nephew D-RAD 2.4MM X 10MM S-T LOCKING SCREW, REF 74692410, QTY (1), STERILE R | One lot of D-RAD Self-Taping Locking Screws used with the Distal Radius Fracture Kit were machined out of specification. Screws measured over tolerance within the head thread form by 0.002-0.003 inch. | accessdata.fda.gov |
| February 1, 2018 | 79247 | Class II | Terminated | smith&nephew, LEGION HK FEMORAL WEDGE (WEDGE AND SCREW), 5 MM, SIZE 5, REF 71422159, QTY: (1), STERILE The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, | The screws package with devices within lot 14AAP6352A were 5 MM instead of 10MM and are too short to be used with the Legion HK Distal Wedge Size 5. | accessdata.fda.gov |
| January 15, 2018 | 83596 | Class II | Completed | LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT, REF 71423432 Product Usage: The constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior crucia | The affected products were inadvertently packaged with an incorrect screw component. | accessdata.fda.gov |
| December 13, 2017 | 78840 | Class II | Terminated | Smith & Nephew Taylor Spatial Frame Website software, Catalog Number 71070401. A web-based and mobile application software component of a multilateral external fixation system that is intended for fracture fixation, fixa | In rare circumstances, when surgeons use the software to plan the strut adjustment, an inverted image of the frame is generated by the software. The frame will appear inverted in the preview images on the Strut Settings tab. | accessdata.fda.gov |
| December 11, 2017 | 78826 | Class II | Terminated | smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating system, 2.0MM STRAIGHT PLATE, 8 HOLE VLP(R) MIN-MOD, REF 74442024, QTY: (1), STERILE R Bone plates and bone screw | Devices, incorrectly labeled as a VLP MINI-MOD 2.0MM STRAIGHT PLATE 8 HOLE, contained a VLP MINI-MOD 2.0MM STOUT PLATE 8 HOLE and vice versa | accessdata.fda.gov |
| November 29, 2017 | 78672 | Class II | Terminated | smith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate, REF CATALOG NUMBER 72442360N, NON-STERILE, Rx only, (01)00885556456446(10), (11)171116 Bone plates and bone screws from the EVOS Mini-Fragment Plating System are | One lot of EVOS 2.4MM Flex Plate 6 Hole packaging contained templates. | accessdata.fda.gov |
| October 24, 2017 | 78390 | Class II | Ongoing | smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET SCREW PREASSEMBLED IN NAIL | A single lot of INTERTAN 10S 10 MM X 18 CM 130 D was manufactured with the screw inserted upside down. | accessdata.fda.gov |
| October 23, 2017 | 78429 | Class II | Terminated | Radial Osteotome Blade, REF 71369314. Used for cutting or preparing bone. | The expiration date provided on the label is incorrect. | accessdata.fda.gov |
| September 14, 2017 | 78140 | Class II | Terminated | smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE, REF 71421733, STERILE R Product The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis; ost | The Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw. | accessdata.fda.gov |
| August 1, 2017 | 80752 | Class II | Terminated | GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesis | Two lots of Genesis II Non Porous C/R Femoral Size 6 right packaged were distributed containing Genesis II C/R Femoral Size 4 left. | accessdata.fda.gov |
| July 24, 2017 | 77827 | Class II | Terminated | smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar), REF 75102260, NON STERILE, QTY: (1), Rx only The subject cardan is used in conjunction with a curved stem impactor used to impla | The Cardan joint of the Polarstem Cardan could potentially fracture or functionally fail after multiple procedures. | accessdata.fda.gov |
| May 30, 2017 | 77413 | Class II | Terminated | LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c) REF 71441978, ID 22MM | The incorrect Loctite adhesive was used to assemble the impactor heads. | accessdata.fda.gov |
| March 30, 2017 | 76943 | Class II | Terminated | RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 10, REF 71369310, STERILE R, QTY: (1) | The stability data does not support the product labeled with a 10-year shelf life. | accessdata.fda.gov |
| March 22, 2017 | 76934 | Class II | Terminated | PERI-LOC VOLAR DISTAL RADIUS - RIGHT 3H STD HEAD LOCKING PLATE, 62 MM LENGTH, SST PLATE, REF 71823114, QTY: (1) NON-STERILE, Rx only, Smith & nephew, Inc., Memphis TN 38116 | This lot of left plates were laser etched and packaged as right plates. | accessdata.fda.gov |
| March 9, 2017 | 76729 | Class II | Terminated | Peri-Loc(R) VLP 3.5 MM X 6 MM SELF-TAPPING CORTEX SCREW, QTY: (1), STERILE R, REF 71801306 Orthopedic | The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling. | accessdata.fda.gov |
| February 2, 2017 | 76414 | Class II | Terminated | Smith & Nephew Dyonics Saw Blade, Standard, Product Number 3701 | The single use devices are provided sterile and do not have an expiration date on the label. | accessdata.fda.gov |
| November 16, 2016 | 75751 | Class II | Terminated | REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116 | The firm received complaints of cracks in the weld on the head of the mallet. In the reported cases, some of the lead beads and particles escaped from the mallet into the surgical wound. | accessdata.fda.gov |
| November 15, 2016 | 75873 | Class II | Terminated | Modular REDAPT(TM) Hip Systems The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating | All lots of modular neck hip prostheses are being recalled due to a higher than anticipated complaint and adverse event trend. | accessdata.fda.gov |
| August 29, 2016 | 75283 | Class II | Terminated | TANDEM (TM) COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71322040, 71322041, 71322042, 71322043, 71322044, 71322045, 71322046, 71322047, 71322048, 71322049, 71322050, 71322051, 71322052, 71322053, 71322054, 71322055, 71 | Some Bipolar shells were manufactured with an out of specification retainer groove. | accessdata.fda.gov |
| July 6, 2016 | 74617 | Class II | Terminated | SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1), STERILE R, smith&nephew Total hip components are indicated for individuals undergoing primary or revision surgery where other treatments or de | The labels correctly state that the product should be a 25mm screw, but the box contained a longer, 35mm screw. | accessdata.fda.gov |
| May 26, 2016 | 74271 | Class II | Terminated | LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 LEFT, A/P 54.5 MM, M/L 62 MM, REF 71421373 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthr | The surface inside of the femoral component, where cement is applied for adhesion, is below specification. | accessdata.fda.gov |
| March 11, 2016 | 73609 | Class II | Terminated | TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 2 LEFT, STERILE R, REF 12, S&N 7500257, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis | The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery. | accessdata.fda.gov |
| January 18, 2016 | 73164 | Class II | Terminated | LEGION(TM) HEMI STEPPED, TIBIAL SCREW-ON WEDGE, REF 71421147, QTY 1, 5 MM, SIZE 5-6 LT-LAT / RT-MDL; Tibial knee prosthesis, augment. | The package for catalog item, a LEGION Hemi Stepped Tibial Wedge, 5 MM Size 5-6 LT-LAT/ RT-MDL, should include both a screw-on hemi stepped tibial wedge and two tibial wedge screws to affix the wedge to the tibial baseplate. A complaint was received indicating that the screws packaged with the wedge were too long. | accessdata.fda.gov |
| November 16, 2015 | 72719 | Class II | Terminated | BIRMINGHAM HIP RESURFACING MODULAR HEAD, REF numbers: 74121238, MODULAR HEAD 38 MM -8MM 74121242, MODULAR HEAD 42 MM -8MM 74121246, MODULAR HEAD 46 MM -8MM 74121250, MODULAR HEAD 50 MM -8MM 74121254, MODULAR HEAD 54 MM - | The 16 devices distributed in the United States were incorrectly labeled as the monoblock Birmingham Hip Modular Head, with labeling not cleared for marketing in the US. The actual devices were monoblock Modular Femoral Head for hemiarthroplasty use. | accessdata.fda.gov |
| November 9, 2015 | 72866 | Class II | Terminated | Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDARD, FOR CEMENTED USE ONLY WITH JOURNEY PEG, STERILE EO, Rx only, REF Number: 71934490 knee implant. | One lot of 35 mm patella implants is labeled as 32 mm. These implants have pegs which are spaced proportionally; therefore the mismatch prevents the pegs from properly aligning with pre-drilled holes during implantation. | accessdata.fda.gov |
| October 20, 2015 | 72655 | Class II | Terminated | Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, LEFT - 62 MM, STERILE R, Rx only, REF Numbers: 71863110 Bone fixation plate | The devices were packaged and laser marked anatomically incorrect. The Left plates were laser marked and packaged as Right plates and the Right plates were laser marked and packaged as Left plates. | accessdata.fda.gov |
| June 3, 2015 | 71985 | Class II | Terminated | Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD, STERILE R, Rx only, REF Numbers: 74121138 (38 MM), 74123140 (40 MM), 74121142 (42 MM), 74123144 (44 MM), 74121146 (46 MM). Product Usage: Hip joint prosthesis | The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which were higher than established benchmarks. | accessdata.fda.gov |
| May 6, 2015 | 71330 | Class II | Terminated | R3(TM) 22 MM I.D., 52 MM O.D. CONSTRAINED LINER, REF 71339152, QTY: (1), STERILE EO. Product Usage: The R3 Constrained liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The C | The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell. | accessdata.fda.gov |
| November 4, 2014 | 69759 | Class II | Terminated | LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 4, LEFT, REF 71425004, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic. | The stem taper on this device is undersized; the gauge point is not deep enough. | accessdata.fda.gov |
| July 2, 2014 | 68792 | Class II | Terminated | TRIGEN(R) INTERTAN(TM) 10MM X 18 CM NAIL, 125o, REF 71675201, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 11.5MM X 18 CM NAIL, 125o, REF 71675202, QTY (1), STERILE R, Smith & Nephew | There was an error in manufacturing which resulted in the proximal lag screw hole being positioned incorrectly in several batches of TRIGEN(R); INTERTAN(TM); NAILS. | accessdata.fda.gov |
| April 4, 2014 | 68043 | Class II | Terminated | TRIGEN INTERTAN NAIL: (1) REF 71675201, 10 MM X 18 CM, 125 degree, (2) REF 71675202, 11.5 MM X 18 CM, 125 degree, (3) REF 71675203, 13 MM X 18 CM, 125 degree, (4) REF 71675204, 10 MM X 20 CM, 125 degree, (5) REF 71675205 | A manufacturing error resulted in the set screw being inserted too deep in the affected nails. | accessdata.fda.gov |
| January 23, 2014 | 67404 | Class II | Terminated | Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, Smith & Nephew, Inc. Indications for use include cemented or uncemented total hip arthroplasty for rheumatoid arthritis; osteoarthritis; post t | Inner spherical radius of the shell is undersized. | accessdata.fda.gov |
| November 25, 2013 | 67042 | Class II | Terminated | REFLECTION(R), MICROSTABLE(R), ACETABULAR LINER, 20o OVERHANG, 28 MM ID, 54-56 OD, QTY: (1), STERILE EO, REF 71742854, Smith & Nephew, Inc. Memphis, TN 38116 USA. Orthopaedic. | One batch of the Reflection(TM) Polyethylene Acetabular Liners may be out of tolerance causing the liner not to fully seat into the shell. | accessdata.fda.gov |
| October 7, 2013 | 66545 | Class II | Terminated | GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. Product Usage: orthopaedic | Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa. | accessdata.fda.gov |
| August 27, 2013 | 66333 | Class II | Terminated | GENESIS(R) II, POSTERIOR STABILIZED ARTICULAR INSERT, SIZE 1-2, 13 MM QTY: (1), REF 71420806, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic | The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed. | accessdata.fda.gov |
| July 8, 2013 | 65738 | Class II | Terminated | GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL, SIZE 3-4, A/P 48 MM, M/L 68 MM, QTY 1, NON-STERILE, REF 71430490, Product Usage: Orthopedic | The products were produced using the wrong color material, resulting in the devices being red (used for deep dished inserts) instead of blue (used for cruciate retaining inserts). | accessdata.fda.gov |
| May 29, 2013 | 65370 | Class II | Terminated | R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD, QTY: (1), STERILE H2O2, REF 71335762. Orthopaedic. | One batch of 60 mm 20o R3 XLPE liner may be laser etched and packaged as a 62 mm 20o liner and one batch of 62 mm 20o R3 XLPE liner may be laser etched and packaged as a 60 mm 20o liner. | accessdata.fda.gov |
| March 6, 2013 | 64669 | Class II | Terminated | TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF 71645437, Smith & Nephew, Inc. Memphis, TN 38116 USA orthopedic surgery | One batch of 4.5 mm diameter Trigen Low-Profile Bone Screws were incorrectly anodized with a gold coating (indicating a 5 mm diameter) instead of a gray coating (indicating a 4.5 mm diameter). | accessdata.fda.gov |
| February 7, 2013 | 64342 | Class II | Terminated | INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162380, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 80 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for intramedullary rod fixation. | 75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm screws were packaged and labeled using a 75 mm screw outer box and label. | accessdata.fda.gov |
| August 22, 2012 | 63089 | Class II | Terminated | 12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS ONLY CO-CR, REF 71352112, Smith & Nephew, Inc. Memphis, TN 38116 USA. USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS. | Modular necks were manufactured out of specification by a vendor; the taper provide is undersized. | accessdata.fda.gov |
| April 13, 2012 | 61767 | Not yet classified | Terminated | 4.8 MM X 1.8 MM DRILL FOR HA COATED HALF PINS, CANNULATED, REF 71070845, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device. | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | accessdata.fda.gov |
| March 11, 2011 | 58324 | Not yet classified | Terminated | R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 32 MM I.D. 48 MM O.D., REF 71338948, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06 Usage: Primary total hip arthroplasty due to non-inflammatory arthri | During the manufacturing process for several batches of R3 Ceramic Liners, the titanium rings were pressed onto the ceramic component with a higher force than allowed by manufacturing specifications. This has the potential to result in lower than expected strength for the liners. | accessdata.fda.gov |
| October 15, 2010 | 57047 | Not yet classified | Terminated | smith & nephew TRIGEN SURESHOT Distal Targeting System, Trauma Interface, V2.0.2, Trauma Launcher V1.01.1 Product is intended to be an intraoperative image-guided localization system. It is a computer-assisted orthopedic | Targeting software has been found to provide erroneous targeting when used with the 13 mm TAN/FAN Left nails. | accessdata.fda.gov |
| August 13, 2010 | 56805 | Not yet classified | Terminated | R3 (TM) 22 MM I.D., 52 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339152, STERILE EO, QTY 1, Smith & Nephew, Inc., Hip prosthesis acetabular component. Acetabular Liner | The firm received reports of a femoral head popping out of the liner intraoperatively. | accessdata.fda.gov |
| July 20, 2010 | 56402 | Not yet classified | Terminated | PERI-LOC (R), 3.5 MM ANTEROLATERAL DISTAL TIBIA PLATE, 10 HOLE, RIGHT - 148 MM, REF 71800710, QTY: (1), STERILE R, CE 0086, Smith & Nephew, Inc., Memphis, TN 38116, USA, EC REP: Smith & Nephew Orthopaedics Gmbh, Tuttling | Inner packaging of sterile product was not sealed. Lack of sterility assurance. | accessdata.fda.gov |
| June 28, 2010 | 56187 | Not yet classified | Terminated | CERCLAGE WIRE, 0.6 MM DIA. X 175 MM LENGTH, SST, REF 71163006, QTY: (6), STERILE R, CE 008, 2020/07, Smith & Nephew, Inc., Memphis, TN 38116, EC REP: Smith & Nephew Orthopaedics GmbH, Tuttlingen, Germany Usage: Bone frac | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, compromising sterility. | accessdata.fda.gov |
| April 20, 2010 | 55673 | Not yet classified | Terminated | GENESIS II TIBIAL DRILL GUIDE, REF 71440238, SIZE 5, QTY: (1), NON-STERILE, Smith & Nephew, Inc., Memphis, TN 38116, USA Drill guide used as manual surgical instrument during knee replacement surgeries. | Markings for the drill guides are on the incorrect side: left is printed on right side and right is printed on the left side | accessdata.fda.gov |
| January 14, 2010 | 54891 | Not yet classified | Terminated | PROMOS Inclination set, SIZE 20mm, REF 42 180, S&N 75006722, QTY: (1), STERILE R, Smith & Nephew Orthopaedics AG, CH-Rotkreuz-Switzerland. The device is used as a semi-constrained, metal/polymer cemented shoulder prosthe | Firm received complaints of Inclination Set Screws fracturing. | accessdata.fda.gov |
| June 5, 2009 | 52228 | Not yet classified | Terminated | Exogen 4000+ Ultrasound Bone Healing System, SAFHS, Part Numbers 71034100 and 71034101, Rx only, Smith & Nephew, 1450 Brooks Road, Memphis TX 38116. The device is used for the non-invasive treatment of established nonuni | Problems with transducer may result in a reduced ultrasound output. | accessdata.fda.gov |
| January 23, 2009 | 54269 | Not yet classified | Terminated | JOURNEY " UNI TIBIAL BASEPLATE, LEFT MEDICAL/TIGHT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422221, FOR CEMENTED USE ONLY, QTY: (1), STERILE R, SMITH & NEPHEW, INC. MEMPHIS, TN 38116 | The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instability and premature wear of the construct. | accessdata.fda.gov |
| January 23, 2009 | 52617 | Not yet classified | Terminated | Smith & Nephew Orthopaedics PIP (proximal Interphalangeal) FIXATION HINGE KIT, REF 101638, for external fixation of finger joint. | Hinge failure: The product is cracking or breaking during use. | accessdata.fda.gov |
| January 23, 2009 | 52615 | Not yet classified | Terminated | Oxinium Femoral Head, 36 MM OD-3, 12/14 Taper, REF 71343603, Sterile, Smith & Nephew, Memphis TN 38116 | Radius at the end of the taper of the femoral implant is smaller than specification. This error could result in the tapers not locking fully or properly on femoral stems or in causing impingement and/or increased wear debris. The deficiency may not be noticed by the user. Impingement and/or wear debris may lead to revision. | accessdata.fda.gov |
| January 22, 2009 | 52582 | Not yet classified | Terminated | LEGION Pressfit Stem, Straight, 10 MM X 160 MM, REF 71424043, Sterile, Smith & Nephew, Memphis TX 38116. The device is used for Orthopedic Knee Implants. | Products were mispackaged. | accessdata.fda.gov |
| January 22, 2009 | 52177 | Not yet classified | Terminated | IMHS CP, 3.2mm, Tip Threaded Guide Pin, REF71687000, for use with IntraMedullary Hip Screw in orthopedic surgery. | Incorrect depth gauge mark etched onto guide wire pin. Guide pin is too long. | accessdata.fda.gov |
| January 12, 2009 | 52616 | Not yet classified | Terminated | Tandem Unipolar, 46 MM CO-CR, REF 126646, Sterile, Smith & Nephew, Memphis TX 38116 Designed for use with femoral stems and acetabular components distributed by Smith & Nephew. | 46 mm Femoral head was mismarked and packaged as being 45 mm | accessdata.fda.gov |
| November 21, 2008 | 50545 | Not yet classified | Terminated | PROMOS Releasing Clamp (3 parts), REF, S&N 75006600, Rx only, QTY(1), non-sterile Instrument for prosthesis, shoulder, semi-constrained, metal/polymer cementer | The product was breaking during use. | accessdata.fda.gov |
| November 21, 2008 | 50543 | Not yet classified | Terminated | Reflection, Microstable Acetabular Liner, REF 71740250, 32mm ID, 50-52 OD, 1 each, sterile EO. Component is a liner used to hold the femoral head used in total hip replacement arthroplasty procedures. | Liners measuring 28 mm ID and were mismarked as 32 mm. | accessdata.fda.gov |
| August 5, 2008 | 49129 | Not yet classified | Terminated | Caption Disposable Platelet Concentrator Kit, Ref 71178200, 1 each, Sterile, Smith & Nephew, Inc. Memphis, TN 38116. | Product contained a syringe whose package seal integrity can be adversely affected when the product is exposed to low atmospheric pressure. This may occur during shipping. | accessdata.fda.gov |
| April 22, 2008 | 48429 | Not yet classified | Terminated | TRIGEN Hind Foot Fusion Nail, 10mm X 25mm Left, REF 71701025L. The device is indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot. | One of the distal locking screw holes on a hindfoot fusion nail was drilled with an incorrect trajectory. | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- All makers of Plate, Fixation, Bone
- All makers of Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
- All makers of Rod, Fixation, Intramedullary And Accessories
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Updated October 30, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.