Data / Medical devices / United States / Smith & Nephew Inc.
Smith & Nephew Inc.: FDA-registered device maker in Andover, MA, United States, 154 510(k) clearances
Smith & Nephew Inc. is registered with the FDA (registration 3003604053) in Andover, MA, United States. It lists 66 device types. The FDA files 154 510(k) clearances under its listings, the newest dated July 9, 2026. 36 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003604053
- Address
- ENDOSCOPY 150 Minuteman Rd, Andover, MA, United States, 01810
- Owner or operator
- Smith & Nephew, Inc. (1020279)
- Roles
- Manufacturer, Specification developer
- First device listed
- February 22, 1978
- Registered through
- 2026
- Brand names listed
- "BIORAPTOR KNOTLESS SUTURE ANCHOR, SHOULDER CLOSE", (6) MINITAPE (BLUE) 39.5, (6) MINITAPE (COBRAID BLUE) 39.5, (6) MINITAPE (COBRAID WHITE) 39.5, (curette, probe, rasp, osteotome ), 1.2 ENDOBUTTON CL ULTRA PAC, 1.2 RAP-PAC A LATEX FREE, 1.2 RAP-PAC A, 72202796 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 154.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 9, 2026 | K261968 | Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982) | MBI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 6, 2026 | DEN250037 | TESSA Spatial Surgery System; INTELLIO Tablet (72205455) | SIQ | Unknown | Smith & Nephew, Inc. | accessdata.fda.gov |
| June 25, 2025 | K251627 | BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue) | MBI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| November 26, 2024 | K242631 | REGENETEN Bioinductive Implant | OWY | Substantially Equivalent | Smith & Nephew Inc., Endoscopy Div. | accessdata.fda.gov |
| June 20, 2024 | K241435 | Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, co-braid-blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, co-braid-blue | MBI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 17, 2024 | K233730 | Footprint Mini PK, 3.5mm Suture Anchor | MBI | Substantially Equivalent | Smith & Nephew | accessdata.fda.gov |
| September 8, 2023 | K232457 | Q-FIX ULTRA All-Suture Anchor | MBI | Substantially Equivalent | Smith & Nephew | accessdata.fda.gov |
| August 9, 2023 | K231376 | Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape) | MBI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 4, 2023 | K232005 | HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue Cobraid) | MBI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| May 11, 2023 | K222501 | Regeneten Bioinductive Implant | OWY | Substantially Equivalent | Smith and Nephew, Inc. | accessdata.fda.gov |
| February 17, 2023 | K222971 | ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device; ULTRABUTTON TIB SMALL Adjustable Fixation Device; ULTRABUTTON TIB MEDIUM Adjustable Fixation Device; ULTRABUTTON TIB LARGE Adjustable Fixation Device | MBI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 20, 2022 | K221740 | SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NETWORK ENABLED (72205447), SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NON-NETWORK ENABLED (72205448) | GCJ | Substantially Equivalent | Smith and Nephew, Inc. | accessdata.fda.gov |
| September 6, 2022 | K221929 | Smith+Nephew INTELLIO Tablet | ODA | Substantially Equivalent | Smith+Nephew | accessdata.fda.gov |
| May 13, 2021 | K203566 | Tablet Application | ODA | Substantially Equivalent | Smith & Nephew | accessdata.fda.gov |
| February 1, 2021 | K203393 | FAST-FIX FLEX | GAT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 20, 2020 | K201349 | Smith+Nephew Arthroscopes | HRX | Substantially Equivalent | Smith & Nephew | accessdata.fda.gov |
| July 17, 2020 | K201198 | S+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparoscopes, 4KO, Autoclavable | GCJ | Substantially Equivalent | Smith & Nephew | accessdata.fda.gov |
| March 18, 2020 | K193558 | HEALICOIL Knotless Suture Anchors | MAI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| February 27, 2020 | K192876 | INTELLIO Tablet Application | ODA | Substantially Equivalent | Smith & Nephew | accessdata.fda.gov |
| August 23, 2019 | K191177 | LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera Head | GCJ | Substantially Equivalent | Smith and Nephew, Inc. | accessdata.fda.gov |
| May 21, 2019 | K190367 | Smith & Nephew Tablet Application | QGY | Substantially Equivalent | Smith & Nephew | accessdata.fda.gov |
| March 12, 2019 | K183232 | Double ENDOBUTTON Fixation Device | HTN | Substantially Equivalent | Smith and Nephew, Inc. | accessdata.fda.gov |
| September 28, 2018 | K181746 | MICRORAPTOR Knotless Suture Anchor | MAI | Substantially Equivalent | Smith and Nephew, Inc. | accessdata.fda.gov |
| August 1, 2018 | K181772 | NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0) | GAT | Substantially Equivalent | Ceterix Orthopaedics, Inc. | accessdata.fda.gov |
| May 30, 2018 | K180361 | MICRORAPTOR REGENESORB Suture Anchor | MAI | Substantially Equivalent | Smith and Nephew, Inc. | accessdata.fda.gov |
| March 29, 2018 | K180531 | NovoStitch Pro Meniscal Repair System | GAT | Substantially Equivalent | Ceterix Orthopaedics, Inc. | accessdata.fda.gov |
| June 27, 2017 | K171794 | Smith & Nephew 25 Fluid Management System | HRX | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| June 8, 2017 | K162996 | INVISIKNOT Ankle Syndesmosis Repair Kit | HTN | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| December 7, 2016 | K163034 | SUTUREFIX Curved Suture Anchor | MBI | Substantially Equivalent | Smith and Nephew, Inc. | accessdata.fda.gov |
| June 2, 2016 | K153606 | LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera Coupler, Tablet Application | GCJ | Substantially Equivalent | Smith & Nephew | accessdata.fda.gov |
| December 2, 2015 | K152566 | PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to Twinfix Ti Quick-T, Twinfix FT PK, Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors, FOOTPRINT Ultra OK Suture Anchors, BIORAPTOR 2.9 Suture Anchor, BIORAPTOR 2.3 PK Suture Anchor, OSTEORAPTOR Suture Anchor, BIORAPTOR Knotless Suture Anchor, HEALICOIL PK Suture Anchor (formerly Next Generation Fully Threaded Suture Anchor), Bioraptor Curved 2.3 PK Suture Anchors | MBI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 28, 2015 | K151105 | Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew Suture Anchors - TAG Bioraptor Suture Anchor 7209317, 7209318, Smith and Nephew Suture Anchors - Bioraptor 2.3 PK Suture Anchor, Smith and Nephew Suture Anchors - Osteoraptor Suture Anchor, Smith and Nephew Suture Anchors - Twinfix Ultra HA Suture Anchor, Smith and Nephew Suture Anchors - OSTEORAPTOR Curved Suture Anchors, Smith and Nephew Suture Anchors - Ultra Fast-Fix Meniscal Repair System, Ultra Fa | MAI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 13, 2015 | K142948 | BIOSURE REGENESORB interference Screw | MAI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| May 13, 2014 | K140970 | ONE-PIECE PEEK FUSION IMPLANT | HWC | Substantially Equivalent | Mtp Solutions, LLC | accessdata.fda.gov |
| April 7, 2014 | K133235 | THREADED PEEK K-WIRE | MBI | Substantially Equivalent | Mtp Solutions, LLC | accessdata.fda.gov |
| March 28, 2014 | K133515 | PEEK FUSION IMPLANT | HWC | Substantially Equivalent | Mtp Solutions, LLC | accessdata.fda.gov |
| March 26, 2014 | K140300 | COLLAGEN TENDON SHEET-DDI (CTS-DDI) | OWY | Substantially Equivalent | Rotation Medical, Inc. | accessdata.fda.gov |
| January 30, 2014 | K133229 | TITANIUM SUTURE ANCHOR | MBI | Substantially Equivalent | Mtp Solutions, LLC | accessdata.fda.gov |
| January 16, 2014 | K133727 | Q-FIX SUTURE ANCHOR, 1.8MM; Q-FIX SUTURE ANCHOR, 2.8MM; DRILL, DRILL GUIDE AND OBTURATOR, 1.8MM & 2.8MM, FIRSTPASS SUTU | MBI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| December 5, 2013 | K132079 | TFCC FAST-FIX KIT | GAT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 30, 2013 | K132357 | SMITH & NEPHEW ULTRATAPE | GAT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 17, 2013 | K132636 | DYONICS PLAN HIP IMPINGEMENT PLANNING SYSTEM | LLZ | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 29, 2013 | K131635 | ROTATION MEDICAL BONE STAPLE (RMB STAPLE) | MBI | Substantially Equivalent | Rotation Medical, Inc. | accessdata.fda.gov |
| July 12, 2013 | K131637 | ROTATION MEDICAL SOFT TISSUE STAPLE (RMST STAPLE) | GDW | Substantially Equivalent | Rotation Medical, Inc. | accessdata.fda.gov |
| April 11, 2013 | K123393 | HEALICOIL SUTURE ANCHOR WITH REGENESORB | MAI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| March 18, 2013 | K122059 | ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR ALL-SUTURE ANCHORS | MBI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| March 11, 2013 | K121904 | GYNECOLOGY STERILIZATION TRAY | KCT | Substantially Equivalent | Smith & Nephew Inc., Endoscopy Division | accessdata.fda.gov |
| February 20, 2013 | K123425 | TWINFIX TI 3.5MM SUTURE ANCHOR WITH TWO ULTRABRAID SUTURE #2 WITH NEEDLES, SL | MBI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 23, 2013 | K123579 | FOOTPRINT ULTRA PK4.5MM AND 5.5MM SUTURE ANCHOR, SL | MBI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 8, 2013 | K122048 | COLLAGEN TENDON SHEET-D | FTM | Substantially Equivalent | Rotation Medical, Inc. | accessdata.fda.gov |
| October 18, 2012 | K121861 | SMITH & NEPHEW ULTRA FAST-FIX MENISCAL REPAIR SYSTEM, SMITH & NEPHEW ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEM, SMITH & N | GAT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 17, 2012 | K120151 | NEBULAE I | HIF | Substantially Equivalent | Northgate Technologies, Inc. | accessdata.fda.gov |
| January 20, 2012 | K113294 | SMITH & NEPHEW HEALICOIL PK SUTURE ANCHOR | MBI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| November 14, 2011 | K111843 | ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM | OLO | Substantially Equivalent | Smith & Nephew Inc., Endoscopy Div. | accessdata.fda.gov |
| June 24, 2011 | K110545 | SMITH & NEPHEW NEXT GENERATION FULLY THREADED PEEK SUTURE ANCHOR (NGFTSA PK) | MBI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 8, 2011 | K101377 | SMITH & NEWPHEW ULTRABRAID II SUTURE | GAT | Substantially Equivalent | Smith & Newphew, Inc. | accessdata.fda.gov |
| February 3, 2011 | K103309 | OSTEORAPTOR CURVED 2.3 SUTURE ANCHORS | MAI | Substantially Equivalent | Smith & Nephew Endoscopy, Inc. | accessdata.fda.gov |
| January 5, 2011 | K102982 | ENDOBUTTON DIRECT | MAI | Substantially Equivalent | Smith & Nephew Inc., Endoscopy Division | accessdata.fda.gov |
| January 5, 2011 | K102544 | SMITH & NEPHEW HIP ARTHROSCOPY REPAIR INSTRUMENT TRAY | KCT | Substantially Equivalent | Smith & Nephew Inc., Endoscopy Div. | accessdata.fda.gov |
| December 13, 2010 | K102660 | BIORAPTOR CURVED 2.3 PK SUTURE ANCHORS | MBI | Substantially Equivalent | Smith & Nephew Endoscopy, Inc. | accessdata.fda.gov |
| November 22, 2010 | K102122 | SMITH & NEPHEW MILTI-PURPOSE STERILIZATION TRAY MODEL 72202428 | KCT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| September 14, 2010 | K092551 | SMITH & NEPHEW INSTRUMENT TRAYS | KCT | Substantially Equivalent | Smith & Nephew Inc., Endoscopy Div. | accessdata.fda.gov |
| April 19, 2010 | K100159 | SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR | MBI | Substantially Equivalent | Smith & Nephew Inc., Endoscopy Div. | accessdata.fda.gov |
| March 5, 2010 | K093943 | BIOSURE SYNC TIBIAL FIXATION DEVICE, 6MM, 8MM,10MM,12MM | MBI | Substantially Equivalent | Smith & Nephew Inc., Endoscopy Div. | accessdata.fda.gov |
| December 17, 2009 | K093428 | SMITH & NEPHEW KNOTLESS INSTABILITY ANCHOR | MBI | Substantially Equivalent | Smith & Nephew Endoscopy, Inc. | accessdata.fda.gov |
| July 2, 2009 | K091627 | SMITH & NEPHEW INSTRUMENT TRAYS | KCT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| March 18, 2009 | K090562 | SMITH & NEPHEW INSTRUMENT TRAYS | KCT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 30, 2009 | K083635 | SMITH & NEPHEW BIOSURE PK INTERFERENCE SCREW | MBI | Substantially Equivalent | Smith & Nephew Endoscopy, Inc. | accessdata.fda.gov |
| January 30, 2009 | K083226 | SMITH & NEPHEW PEEK INTERFERENCE SCREW | MBI | Substantially Equivalent | Smith & Nephew Endoscopy, Inc. | accessdata.fda.gov |
| October 21, 2008 | K082095 | ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE | HTN | Substantially Equivalent | Smith & Nephew Endoscopy, Inc. | accessdata.fda.gov |
| August 26, 2008 | K081511 | 2.0 PK SUTURE ANCHOR T, 2.0 PK SUTURE ANCHOR S | MBI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| May 21, 2008 | K073551 | SMITH & NEPHEW INSTRUMENT TRAYS | KCT | Substantially Equivalent | Smith & Nephew Inc., Endoscopy Div. | accessdata.fda.gov |
| April 23, 2008 | K080358 | PLLA, HA SCREW | HWC | Substantially Equivalent | Smith & Nephew Inc., Endoscopy Div. | accessdata.fda.gov |
| March 18, 2008 | K080560 | HENKE SASS WOLF OF AMERICA ARTHROSCOPE | HRX | Substantially Equivalent | Henke Sass Wolf of America, Inc. | accessdata.fda.gov |
| September 18, 2007 | K072322 | ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS | GAT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 17, 2007 | K071586 | BIORAPTOR 2.3 PK SUTURE ANCHOR | MBI | Substantially Equivalent | Smith & Nephew Inc., Endoscopy Division | accessdata.fda.gov |
| February 22, 2007 | K070266 | 560 HIGH DEFINITION CAMERA SYSTEM | GCJ | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 19, 2007 | K062849 | SMITH & NEPHEW DUONICS POWER II SHAVER SYSTEM | HRX | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 13, 2006 | K060777 | SMITH & NEPHEW MODEL 660HD IMAGE MANAGEMENT SYSTEM | GCJ | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| February 14, 2006 | K060123 | LEVELERT II FLUID LEVEL SENSOR | FLN | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| May 25, 2005 | K050898 | SMITH & NEPHEW VULCAN ARTICULAR CARTILAGE PROBE, MODEL 721XXXX | GEI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 20, 2005 | K050580 | SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS | HRX | Substantially Equivalent | Smith & Nephew Endoscopy, Inc. | accessdata.fda.gov |
| March 24, 2005 | K050163 | HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPE | GCJ | Substantially Equivalent | Henke Sass Wolf of America, Inc. | accessdata.fda.gov |
| January 12, 2005 | K043395 | SMITH & NEPHEW VIDEOARTHROSCOPE | HRX | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 19, 2004 | K040542 | SMITH & NEPHEW GTS SLEEVE AND GTS TAPERED SCREW | HWC | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 27, 2004 | K041328 | SMITH & NEPHEW ELECTROBLADE RESECTOR/ADAPTOR | GEI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| June 7, 2004 | K041216 | SMITH & NEPHEW ULTRABRAID SUTURE | GAT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 14, 2004 | K040331 | SMITH AND NEPHEW TITANIUM INTERFERENCE SCREWS | HWC | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 29, 2003 | K032119 | PARAGON MEDICAL SURGICAL INSTRUMENT DELIVERY SYSTEM VARIOUS | KCT | Substantially Equivalent | Paragon Medical, Inc. | accessdata.fda.gov |
| September 26, 2003 | K032680 | SMITH & NEPHEW 300XL XENON LIGHT SOURCE-HERMES READY MODEL, 7210045 | GCJ | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 8, 2003 | K032224 | BIORCI SCREW | HWC | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| February 20, 2003 | K030196 | DYONICS POWER CONTROL UNIT | HRX | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 2, 2002 | K012105 | POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM | KCT | Substantially Equivalent | Symmetry Medical, Inc. | accessdata.fda.gov |
| February 1, 2002 | K012314 | DYONICS ELECTROBLADE RESECTOR | GEI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| December 7, 2001 | K993535 | METAPAK MULTI-PURPOSE INSTRUMENT TRAY | FRG | Substantially Equivalent | Riley Medical, Inc. | accessdata.fda.gov |
| August 29, 2001 | K003198 | VULCAN TAC PROBES, MODEL 911XXX | HRX | Substantially Equivalent | Oratec Interventions, Inc. | accessdata.fda.gov |
| March 7, 2001 | K002274 | SMITH & NEPHEW SUTURE HAPLA INTERFERENCE SCREW | HWC | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| March 1, 2001 | K003893 | VULCAN ABLATOR ELECTROSURGICAL PROBES, VULCAN LIGAMENT CHISEL ELECTROSURGICAL PROBES, MODEL 91000X,91002X,91300X | HRX | Substantially Equivalent | Oratec Interventions, Inc. | accessdata.fda.gov |
| May 4, 2000 | K000691 | VULCAN ELECTROSURGICAL PROBES: VULCAN MICRO LIGAMENT CHISELS, VULCAN LIGAMENT CHISELS, VULCAN EFLEX LIGAMENT CHISELS | HRX | Substantially Equivalent | Oratec Interventions, Inc. | accessdata.fda.gov |
| April 3, 2000 | K000797 | OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01 | JDR | Substantially Equivalent | Orthopaedic Biosystems, Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 29, 2024 | 95654 | Class II | Ongoing | BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor. | Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device. | accessdata.fda.gov |
| August 12, 2024 | 95178 | Class II | Ongoing | ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 2504-1 | Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility | accessdata.fda.gov |
| April 8, 2021 | 87717 | Class II | Terminated | CANNU-Flex SILK Interference Screws 6 mmx 30 mm - Product Usage: used for interference fixation of bone-tendon-bone of soft tissue grafts in anterior cruciate ligament reconstruction, Part Number: 014208 | Mislabeled box contained a 6mm x 20mm screw instead of 6mm x 30mm screw | accessdata.fda.gov |
| September 21, 2020 | 86502 | Class II | Terminated | 5.5MM Arthrogarde Hip Access Cannula | The J Lock feature on the cannula body was manufactured incorrectly, preventing the cannula from locking into an irrigation extender or arthroscope in the correct orientation. | accessdata.fda.gov |
| September 9, 2020 | 86462 | Class II | Ongoing | TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO Absorbable Suture anchors Product Number: 7210309 | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch | accessdata.fda.gov |
| June 24, 2020 | 85984 | Class II | Ongoing | Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage: indicated for use in surgical arthroscopic rotator cuff repair procedures. REF/ Catalog Number : 014771 | The T-Fix sterile package contains only one sleeve instead of two, The device will not perform as intended for the second bone tunnel due to the absence of thesleeve | accessdata.fda.gov |
| June 24, 2020 | 85981 | Class II | Ongoing | SUTUREFIX ULTRA Suture, Product number 72203855 | A packaging error resulted in a XL drill being presented for use instead of the S drill. The XL drill is one inch longer than the S drill. | accessdata.fda.gov |
| January 11, 2016 | 73084 | Class II | Terminated | Smith & Nephew BEAVER Blade 4.0mm Part Number: 72203307 Orthopedic surgical instrument used in hip arthroscopy. | Blade exhibiting fracture during hip arthroscopy procedures | accessdata.fda.gov |
| April 30, 2015 | 71257 | Class II | Terminated | ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended for Meniscal Repair. | Sterility of device maybe compromised | accessdata.fda.gov |
| June 2, 2014 | 68565 | Class II | Terminated | SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Product Code: 72203841 Fastener, fixation, nondegradable, soft tissue | Sterility of device is compromised due to breach in sterile barrier | accessdata.fda.gov |
| August 6, 2013 | 66037 | Class II | Terminated | BIORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture; Part Number: 72200775 Biodegradable suture anchor | Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | accessdata.fda.gov |
| July 14, 2012 | 62617 | Class II | Terminated | Smith & Nephew Dyonics Electroblade Resector, 4.5mm Full Radius Blade, BONECUTTER Part Number: 72202213 Product Usage: The Dyonics Electroblade Resector is indicated for use in arthroscopic surgical procedures of large a | Devices labeled with an expiry period of 48 months instead of 36 months; an additional 12 months for which product and package reliability has not been validated. | accessdata.fda.gov |
| July 3, 2012 | 62525 | Class II | Terminated | Smith & Nephew 5.5 mm TWINFIX Ultra Ti Suture Anchor with two #2 ULTRABRAID sutures (blue, blue-COBRAID) with Needles Product Usage: intended for use for the reattachment of soft tissue to bone Part Number: 72202618 | Distal part of the anchor may break on insertion into bone during surgery | accessdata.fda.gov |
| March 29, 2012 | 61604 | Not yet classified | Terminated | Smith & Nephew 560P High Definition Camera Control Unit Catalog Number: 72201919 The 560P camera system is configured to be connected as a stand-alone system on an endoscopic cart or tower. It is designed for use with th | May experience intermittent loss of video due to a defective board component | accessdata.fda.gov |
| February 6, 2012 | 61138 | Not yet classified | Terminated | Smith & Nephew BIOSURE HA Interference Screw, 7 mm x 25 mm Catalog Number: 72201772. The BIOSURE HA Interference Screw is indicated for fixation of bone-tendon-bone or soft tissue grafts during anterior/posterior cruciat | Mislabeled: The device was labeled as a standard thread screw (P/N 72201772) on pouch and box, however the device contained in the packaging is a reverse thread screw (P/N 72201773). | accessdata.fda.gov |
| November 7, 2011 | 60375 | Not yet classified | Terminated | Smith & Nephew 5.5mm DYONICS BONECUTTER ELECTROBLADE Resector Catalog Number: 7205962. | Manufacturing issue: The distal tip of the outer sheath (return electrode) may detach and become loose in the joint during use. | accessdata.fda.gov |
| September 23, 2011 | 60054 | Not yet classified | Terminated | Smith & Nephew, HD1200 Autoclavable Camera Head Catalog Number: 72203360 Product Usage: Endoscope & Accessories | HD1200 camera heads may cause image issues | accessdata.fda.gov |
| July 26, 2011 | 60518 | Not yet classified | Terminated | Smith & Nephew, SPIDER2 Limb Positioner, including accessories Battery, foot pedal and charger Catalog Number: 72203299. Table, Operating-room, Pneumatic. | SPIDER2 may unlock (loss of traction) resulting in potential movement of the patient when the device is within close proximity to an RF source. Loss of traction can potentially result in the unintended repositioning of the extremity and potential for tissue or cartilage damage | accessdata.fda.gov |
| July 7, 2011 | 59329 | Not yet classified | Terminated | Smith & Nephew, Tendon Stripper, Slotted, 5.0 mm I.D. x 12 working length. Non-Sterile Catalog Number: 013554 Orthopedic Manual Surgical Instrument | Shaft tip (casting) does not meet the SNE 416 specification, which could result in rusting of the Tendon Strippers | accessdata.fda.gov |
| May 19, 2011 | 58894 | Not yet classified | Terminated | Smith & Nephew Hip Arthroscopy Repair Instrument Tray Part Number: 72202732 Device Description-The Smith & Nephew Hip Arthroscopy Repair Instrument Tray is designed to contain and protect reusable surgical instruments du | Hip Arthroscopy Repair Instrument Tray shipped with an incorrect Instructions For Use (IFU) | accessdata.fda.gov |
| May 6, 2011 | 58733 | Not yet classified | Terminated | DYONICS POWER Shaver Blades, 4.5mm Long Curved Full Radius Convex, package of 3. Catalog Number: 7205336 Product Usage: Smith & Nephew DYONICS Disposable Endoscopic Blades are indicated for resection of soft and osseous | Product has insufficient weld between the shaft tube and tip, could result in the tip separating from the shaft tube during use. | accessdata.fda.gov |
| October 14, 2010 | 57041 | Not yet classified | Terminated | Smith & Nephew FAST FIX 360, STRAIGHT NEEDLE Catalog Number; 72202467. Intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as shoulder stabilization (Bankart | FasT-Fix 360 Needle Delivery System may not allow the T-2 (anchor) to advance for implantation. | accessdata.fda.gov |
| April 29, 2010 | 55602 | Not yet classified | Terminated | Smith & Nephew Aimer Endofemoral 3mm Offset (Blue) Catalog Number: 72201713 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery. | Endofemoral Aimer tip may separate due to failure of the soldered joint | accessdata.fda.gov |
| May 27, 2009 | 52211 | Not yet classified | Terminated | DYONICS 25 Fluid Management System Disposable Inflow/Outflow Tubeset With Single Suction Catalog Number: 7211005 | The sterility of the device cannot be assured | accessdata.fda.gov |
| May 7, 2009 | 52042 | Not yet classified | Terminated | Smith & Nephew Endoscopic Disposable Blades: FULL RADIUS BLADE, 5.5MM,SER 3000 Part #: 7206010. DYONICS Series 3000 BONECUTTER Disposable Arthroscopic Surgery Blades are indicated for resection of soft and osseous tissue | Product sterility is compromised due to breach in the sterile packaging. | accessdata.fda.gov |
| August 7, 2008 | 49132 | Not yet classified | Terminated | DYONICS 25 Fluid Management System bag for enclosure of wireless remote control included with Disposable Inflow Tubeset. Catalog # 7211004. Bag is used for remote Control in a sterile field. | Integrity of the remote control bag may not be sufficient to prevent tearing or opening of the bag during use. | accessdata.fda.gov |
| August 21, 2007 | 44704 | Not yet classified | Terminated | Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 6 mm x 20 mm, P/N 7211109, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. | accessdata.fda.gov |
| March 1, 2007 | 37582 | Not yet classified | Terminated | Smith & Nephew Suture Passer 12 inch Part Number: 7209166 | Product is labeled as reusable but there is a potential that the cannulated handle of the product cannot be cleaned adequately following use. | accessdata.fda.gov |
| January 19, 2007 | 37232 | Not yet classified | Terminated | RF Denervation Probe, 5cm, temperature sensing electrodes designed for use in radiofrequency lesion procedures for the treatment of pain. Part Number: 7210270 | Product is non-sterile but labeled incorrectly as sterile. | accessdata.fda.gov |
| September 29, 2006 | 36521 | Not yet classified | Terminated | TruFit CB Plug Size Code Red, 7mm; quantity 1; Part #605-001-03; product labeled as sterile; manufactured by OsteoBiologics, Inc., San Antonio, TX. | Mis-packaging-product in the package may be a different size than indicated on the labeling. | accessdata.fda.gov |
| June 19, 2006 | 35766 | Not yet classified | Terminated | Dyonics Electroblade, 4.5 Full Radius, Valleylab Generator-Compatible Part Number: 7205961 | Sterility seal of the package tray may have gaps/voids compromising the sterility of the device. | accessdata.fda.gov |
| June 19, 2006 | 35765 | Not yet classified | Terminated | TriVex 100SV Resector Kit, 4.5 Part Number: 7205876 | The sterility seal of the package trays may have incomplete seals compromising the sterility of the device | accessdata.fda.gov |
| May 22, 2006 | 35557 | Not yet classified | Terminated | Smith & Nephew Hip Positioning System Ref: 72200624 with System Components: Perineal Post 72200631 Universal Hip Distractor 72200626 Knee Holder 72200627 Well Leg Holder 72200632 Supine Table Extension 72200629 | The Perineal Post may crack or break and the Universal Hip Distractor (carriage) may not maintain adequate traction for the duration of the procedure | accessdata.fda.gov |
| March 24, 2006 | 35033 | Not yet classified | Terminated | FAST-FIX AB Curved Needle Delivery System, Used for meniscal repair. Product Number: 7209399 | The implant consists of a T1 and T2 anchor which are joined together by a suture. The T2 portion of the implant may not advance into the deployment position preventing deployment of the T2 anchor. | accessdata.fda.gov |
| February 19, 2004 | 28423 | Not yet classified | Terminated | Endocoupler, C-Mount 30 mm Focal Length Catalog Number: 7204823, 7204823S | Endocouplers assembled with screws that cannot be effectively sterilized | accessdata.fda.gov |
| October 10, 2003 | 27738 | Not yet classified | Terminated | Smith & Nephew Endocoupler C-Mount 30mm Focal Length Reference: 7204823 and 7204823S (S indicates unit previously serviced) | Hardware of the camera coupler may rust and result in an ineffective sterilization/cleaning process. | accessdata.fda.gov |
Compare with other makers
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- All makers of Camera, Television, Endoscopic, Without Audio
- All makers of Suture, Nonabsorbable, Synthetic, Polyethylene
Updated July 9, 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.