Data / Medical devices / United States / Smith & Nephew Inc.
Smith & Nephew Inc.: FDA-registered device maker in Mansfield, MA, United States, 139 510(k) clearances
Smith & Nephew Inc. is registered with the FDA (registration 1219602) in Mansfield, MA, United States. It lists 51 device types. The FDA files 139 510(k) clearances under its listings, the newest dated July 9, 2026. 14 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1219602
- Address
- Endoscopy 120 Forbes BLVD. Suite 150 / 130 Forbes BLVD., Mansfield, MA, United States, 02048
- 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 139.
| 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 |
| March 26, 2026 | K260601 | REAL INTELLIGENCE CORI | OLO | Substantially Equivalent | Blue Belt Technologies, 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 |
| 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 |
| March 18, 2024 | K240139 | Real Intelligence CORI | OLO | Substantially Equivalent | Blue Belt Technologies, 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 |
| 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 |
| August 19, 2022 | K221224 | REAL INTELLIGENCE CORI | OLO | Substantially Equivalent | Blue Belt Technologies, Inc. | accessdata.fda.gov |
| February 1, 2021 | K203393 | FAST-FIX FLEX | GAT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| June 12, 2020 | K201022 | REAL INTELLIGENCE CORI (CORI) | OLO | Substantially Equivalent | Blue Belt Technologies, Inc. | accessdata.fda.gov |
| March 18, 2020 | K193558 | HEALICOIL Knotless Suture Anchors | MAI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| February 14, 2020 | K193120 | Real Intelligence Cori | OLO | Substantially Equivalent | Blue Belt Technologies, Inc. | 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 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 |
| 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 |
| July 21, 2014 | K140879 | BIOSURE HEALICOIL PK INTERFERENCE SCREW | MBI | 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 |
| 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 |
| 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 |
| 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 |
| November 20, 2012 | K122596 | ARTHROSCOPIC SURGICAL INSTRUMENTS - INTERFERENCE SCREW SYSTEMS | HWC | Substantially Equivalent | Smith & Nephew, 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 |
| January 20, 2012 | K113294 | SMITH & NEPHEW HEALICOIL PK SUTURE ANCHOR | MBI | Substantially Equivalent | Smith & Nephew, Inc. | 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 |
| March 4, 2010 | K093897 | SMITH & NEPHEW FOOTPRINT ULTRA PK SUTURE ANCHOR | MBI | Substantially Equivalent | Smith & Nephew Inc., Endoscopy Div. | accessdata.fda.gov |
| January 28, 2010 | K092508 | FAST-FIX 360 MENISCAL REPAIR SYSTEM, STRIAGHT, CURVED, REVERSE CURVED,FAST FIX 360 AB MENISCAL REPAIR SYSTEM, STRAIGHT, | GAT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| December 17, 2009 | K093428 | SMITH & NEPHEW KNOTLESS INSTABILITY ANCHOR | MBI | Substantially Equivalent | Smith & Nephew Endoscopy, Inc. | accessdata.fda.gov |
| December 15, 2009 | K093228 | SMITH & NEPHEW TWINFIX ULTRA PK SUTURE ANCHOR | MBI | Substantially Equivalent | Smith & Nephew, 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 4, 2008 | K073509 | TWINFIX PK FP SUTURE ANCHOR | HWC | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| December 10, 2007 | K072785 | TWINFIX FT PK | HWC | Substantially Equivalent | Smith & Nephew Inc., Endoscopy Division | 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 |
| May 16, 2007 | K070908 | SMITH & NEPHEW KINSA RC SUTURE ANCHOR | MBI | Substantially Equivalent | Smith & Nephew Inc., Endoscopy Division | accessdata.fda.gov |
| April 12, 2007 | K070167 | ENDOBUTTON DIRECT | MBI | Substantially Equivalent | Smith & Nephew Inc., Endoscopy Division | accessdata.fda.gov |
| June 8, 2006 | K061154 | KINSA SUTURE ANCHOR | MBI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| February 23, 2006 | K053344 | BIORAPTOR SUTURE ANCHOR, TWINFIX 2.8 MM SUTURE ANCHOR, TWINFIX 3.5 MM SUTURE ANCHOR | HWC | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 21, 2005 | K052652 | SMITH & NEPHEW CONTINUOUS LOOP FIXATION DEVICE | GAT | 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 |
| August 8, 2003 | K032224 | BIORCI SCREW | HWC | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 8, 2003 | K032197 | TWIN FIX AB 6.5 MM SUTURE ANCHOR, MODELS 720209, 7210210, 7210211, 7210212 | MAI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 1, 2003 | K031685 | TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318 | HWC | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 4, 2002 | K023021 | MODIFICATION TO SMITH & NEPHEW TWINFIX TI QUICK T | HWC | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| June 27, 2001 | K011299 | SMITH AND NEPHEW 5.00MM ABSORBABLE POLYMER ANCHOR | MAI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| March 7, 2001 | K002274 | SMITH & NEPHEW SUTURE HAPLA INTERFERENCE SCREW | HWC | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 23, 2000 | K002261 | MR-III | GAS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| June 14, 2000 | K001507 | MICROPERFORATION INSTRUMENT | LXH | Substantially Equivalent | Smith & Nephew, 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 |
| February 25, 2000 | K994202 | ACUFEX SPIKED WASHER SYSTEM, ACUFEX SUTURE WASHER SYSTEM, ACUFEX CANCELLOUS SCREW AND SPIKED WASHER SYSTEM | HWC | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 12, 2000 | K992396 | BIORCI SCREW | HWC | Substantially Equivalent | Smith & Nephew Endoscopy, Inc. | accessdata.fda.gov |
| November 18, 1999 | K992945 | RCI FIXATION SCREWS (WITH ASSORTED SIZES) | HWC | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 28, 1999 | K984320 | BIOABSORBABLE INTERFERENCE SCREWS | HWC | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| May 20, 1998 | K981156 | DYONICS INTELIJET INFLOW/OUTFLOW CANNULA | HRX | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 1, 1998 | K980155 | ENDOBUTTON CONTINUOUS LOOP | GAT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| March 9, 1998 | K980092 | SMITH & NEPHEW DYONICS INTELIJET REUSABLE CANNULAS | FRN | Substantially Equivalent - Subject to Tracking Reg. | Smith & Nephew, Inc. | accessdata.fda.gov |
| February 6, 1998 | K972326 | PEBA ANCHOR/SUTURE COMBINATION | MBI | Substantially Equivalent | Orthopaedic Biosystems, Ltd. | accessdata.fda.gov |
| September 19, 1997 | K972599 | ACUFEX SCREW CANNULA | HWC | Substantially Equivalent | Smith & Nephew Endoscopy, Inc. | accessdata.fda.gov |
| April 23, 1997 | K970949 | SMITH & NEPHEW MIS INSTRUMENTS | GCJ | Substantially Equivalent | Smith & Nephew Endoscopy, Inc. | accessdata.fda.gov |
| March 18, 1997 | K970151 | INTERCEPTRE LAPAROSCOPIC INSTRUMENTS | HET | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| December 20, 1996 | K964215 | ACUFEX MOSAICPLASTY COMPREHENSIVE SYSTEM | HRX | Substantially Equivalent | Smith & Nephew Endoscopy, Inc. | accessdata.fda.gov |
| August 14, 1996 | K962789 | SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM | GEY | Substantially Equivalent | Smith & Nephew Endoscopy, Inc. | accessdata.fda.gov |
| July 16, 1996 | K961649 | ACUFEX TIBIAL ANCHOR SCREW & SPIKED WASHER | HWC | Substantially Equivalent for Some Indications | Smith & Nephew Endoscopy, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 24, 2025 | 98051 | Class II | Ongoing | BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener. | Removal of affected lot of screws due to labeling error. | accessdata.fda.gov |
| March 17, 2020 | 85296 | Class II | Ongoing | Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Part Number: 72202901 | Space between the device and the packaging permits excessive movement which could potentially lead to the displacement of the anchors tip protector allowing the tip of the anchor to create a sterile breach. | accessdata.fda.gov |
| December 30, 2019 | 84748 | Class II | Terminated | TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone. | Due to a potential for sterile barrier breach. A complaint was received that indicated the protective tube of the device came off inside the pouch enabling the pointed end of the device to puncture the package causing a breach of the sterile barrier, which could affect the sterility of the device. | accessdata.fda.gov |
| December 11, 2017 | 79700 | Class II | Terminated | Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015 | Packaging design is insufficient to prevent potential sterile barrier breach (pin hole) in Tyvek film of pouch. A limited number of previously recalled devices were inadvertently redistributed. | accessdata.fda.gov |
| March 15, 2017 | 76824 | Class II | Terminated | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 5.5MM Product Number: 72204037 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone | Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming | accessdata.fda.gov |
| July 19, 2016 | 74771 | Class II | Terminated | Smith & Nephew Whipknot Soft Tissue Cinch (USP#5) suture. PN: 7211015 Used during ligament reconstruction. | Sterility compromised due to breach in sterile packaging | accessdata.fda.gov |
| June 15, 2016 | 74449 | Class II | Terminated | Smith and Nephew TWINFIX QUICK-T Knot Pusher Suture Cutter; Part Number: 7209417, for arthroscopic use. | The device could be subject to breaches of its sterile packaging. | accessdata.fda.gov |
| September 10, 2015 | 72205 | Class II | Terminated | Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile Part Number: 7209234 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects. | Sterility of device is compromised due to breach in the packaging | accessdata.fda.gov |
| July 30, 2013 | 72911 | Class II | Terminated | High Flow Irrigation Extender; Part Number 72201021. Arthroscopic accessories are indicated for use in access of the joint capsule. | During arthroscopic surgery, when the scope is moved inside the cannula, the body of the irrigation extender separates, potentially obstructing visualization and causing leakage of the irrigation fluid. The device is removed and a back-up device is used to complete the surgery. | accessdata.fda.gov |
| April 4, 2013 | 72908 | Class II | Terminated | Biosure Driver, Product No: 72201887 For delivery and placement of orthopedic screws. Orthopedic Manual Surgical Instrument | Driver does not meet specification, oversized. Driver may not be able to be fully inserted into the screw, or screw may become stuck on the driver. | accessdata.fda.gov |
| September 3, 2009 | 53299 | Not yet classified | Terminated | AlMER ENDOFEMORAL 4MM OFFSET (PURPLE) Part Number 72201714. The product is an orthopedic device. | Device may have improper Laser Marking, 4mm device may be marked as 6mm and 6mm device may be marked as 4mm. | accessdata.fda.gov |
| July 1, 2005 | 32590 | Not yet classified | Terminated | Smith & Nephew Drill, 2.7mm for BioRaptor Suture Anchor (non-sterile) Reference Number: 7210430 | Drill does not contain laser etched depth marks to assure proper depth of inserted device | accessdata.fda.gov |
| April 6, 2005 | 32160 | Not yet classified | Terminated | Smith & Nephew Grasper, Cupped 3.4mm REF: 011014 | Cupped Grasper Handle marked incorrectly as Duckbill Upbiter | accessdata.fda.gov |
| November 8, 2002 | 25082 | Not yet classified | Terminated | Smith & Nephew ACUFEX Rap-Pac ACL Accessory Kit, Sterile Catalog Number: 014725 | Potential for non sterility as package tray does not contain aeration holes for ETO processing. | accessdata.fda.gov |
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- All makers of Motor, Surgical Instrument, Ac-Powered
- All makers of Passer
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.