Data / Medical devices / United States / DePuy Mitek, Inc.
DePuy Mitek, Inc.: FDA-registered device maker in Raynham, MA, United States, 212 510(k) clearances
DePuy Mitek, Inc. is registered with the FDA (registration 1221934) in Raynham, MA, United States. It lists 82 device types. The FDA files 212 510(k) clearances under its listings, the newest dated February 26, 2026. 26 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1221934
- Address
- 325 Paramount Dr, Raynham, MA, United States, 02767
- Owner or operator
- DEPUY MITEK, A JOHNSON & JOHNSON COMPANY (1221934)
- Roles
- Specification developer
- First device listed
- July 22, 1992
- Registered through
- 2027
- Brand names listed
- 2.3mm Side Effect Electrode, ACCLAIM, ACL GRAFT KNIVES, ADHOC CLAW, ADVANTAGE FIXATION SCREW SYSTEM, AGILITY, ARTHROSCOPE, ARTHROSCOPE (MULTIPLE BRANDS) 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 212.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 26, 2026 | K253791 | PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System Lid | KCT | Substantially Equivalent | DePuy Mitek, Inc. | accessdata.fda.gov |
| February 5, 2025 | K243790 | GRYPHON X Anchor; HEALIX TRANSTEND Anchor | MAI | Substantially Equivalent | Depuy Mitek | accessdata.fda.gov |
| September 11, 2024 | K241010 | HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors | MAI | Substantially Equivalent | Depuy Mitek | accessdata.fda.gov |
| March 15, 2024 | K240441 | MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw | MAI | Substantially Equivalent | Depuy Mitek | accessdata.fda.gov |
| February 26, 2024 | K233675 | FMS VUE Fluid Management and Tissue Debridement System | HRX | Substantially Equivalent | DePuy Mitek, Inc. | accessdata.fda.gov |
| October 6, 2023 | K232492 | 2.7 mm GRYPHON Flex Knotless PEEK Anchor; 2.7 mm GRYPHON Flex Knotless Biocomposite Anchor | MBI | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| December 2, 2022 | K223211 | INHANCETM Shoulder System Humeral Stems and Stemless | PHX | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| August 31, 2022 | K221467 | INHANCETM Reverse Glenoid Peripheral Posts | PHX | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| July 11, 2022 | K221364 | Mitek TIGHT-N Anchor | MBI | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| June 8, 2022 | K212933 | INHANCETM Hybrid Anatomic Glenoid Implant | MBF | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| April 26, 2022 | K220219 | PERMALOOP Suture, PERMATAPE Suture | GAT | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| April 21, 2022 | K212737 | INHANCE Reverse Shoulder System | PHX | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| January 19, 2022 | K212683 | GLOBAL ICON Stemless Shoulder System | PKC | Substantially Equivalent | Depuy(Ireland) | accessdata.fda.gov |
| September 15, 2021 | K212710 | GLOBAL UNITE Platform Shoulder System | PHX | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| July 22, 2021 | K203694 | DELTA XTEND Reverse Shoulder System | PHX | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| July 16, 2021 | K203108 | Ignite Stemless Anatomic Shoulder System | PKC | Substantially Equivalent | Ignite Orthopedics, LLC | accessdata.fda.gov |
| May 20, 2021 | K202716 | Ignite Anatomic Shoulder System | MBF | Substantially Equivalent | Ignite Orthopedics, LLC | accessdata.fda.gov |
| March 18, 2021 | K203186 | DYNATAPE Suture | GAT | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| February 1, 2021 | K203794 | HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture | MBI | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| November 25, 2020 | K202098 | GLOBAL UNITE Platform Shoulder System | PHX | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| August 7, 2020 | K201883 | 6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite Anchor | MBI | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| June 4, 2020 | K200949 | HEALIX ADVANCE Anchor with DYNATAPE Suture | MBI | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| February 24, 2020 | K192855 | DELTA XTEND(TM) Reverse Shoulder System | PHX | Substantially Equivalent | Depuy(Ireland) | accessdata.fda.gov |
| October 4, 2019 | K192448 | Delta Xtend Revers Shoulder System | PHX | Substantially Equivalent | Depuy(Ireland) | accessdata.fda.gov |
| August 22, 2019 | K191242 | HEALIX ADVANCE SP BIOCOMPOSITE Anchor | MAI | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| July 25, 2019 | K190774 | RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL Implant | MBI | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| June 28, 2019 | K191483 | HEALIX ADVANCE Anchor with DYNA+TAPE Sutures | MBI | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| May 17, 2019 | K183077 | Delta Xtend Reverse Shoulder System | PHX | Substantially Equivalent | Depuy(Ireland) | accessdata.fda.gov |
| February 26, 2019 | K182941 | HEALIX ADVANCE SP PEEK Anchor | MBI | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| February 21, 2019 | K183279 | HEALIX Ti ANCHOR with DYNACORD | MBI | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| August 3, 2018 | K181809 | GRYPHON® Anchors with DYNACORD Suture | MAI | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| August 2, 2018 | K181182 | DYNACORD Suture | GAT | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| April 11, 2018 | K173859 | HEALIX ADVANCE Anchor with DYNACORD Suture | MAI | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| January 18, 2018 | K171237 | FMS VUE II Fluid Management and Tissue Debridement System | HRX | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| January 11, 2018 | K170748 | GLOBAL UNITE Platform Shoulder System | PHX | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| November 27, 2017 | K171114 | HEALIX ADVANCE KNOTLESS Anchor | MAI | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| May 18, 2017 | K170639 | HEALIX ADVANCE Anchor with PERMATAPE Suture | MAI | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| December 15, 2016 | K162247 | PERMATAPE | GAT | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| November 7, 2016 | K161638 | SPEEDTRAP Graft Preparation System | GAT | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| July 19, 2016 | K160804 | INTRAFIX(TM) Advance Tibial Fastener System | MAI | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| June 9, 2016 | K161001 | MILAGRO ADVANCE PEEK Interference Screw | MBI | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| March 24, 2016 | K153667 | TRUESPAN Meniscal Repair System | MBI | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| October 6, 2015 | K150209 | Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T and P BR Anchor, Gryphon PEEK Anchor, VersaLok Anchor, Bioknotless BR Anchor, Lupine BR Anchor, PanaLok Anchor,PanaLok Anchor with Orthocord, PanaLok RC QuickAnchor Plus; PanaLok RC QuickAnchor Plus Dual Suture, PanaLok RC QuickAnchor Plus w/Orthocord; PanaLok RC QuickAnchor Plus Dual Suture w/Orthocord, PanaLok Loop Anchor, Lupine Loop Anchor, PanaLok RC Lop Anchor, BioKnotless Anchor, BioKnotless RC Anchor, RC Loop Anc | MAI | Substantially Equivalent | Depuy Mitek, A Johnson and Johnson Company | accessdata.fda.gov |
| May 21, 2015 | K143660 | Milagro / Milagro Advance Interference Screw | MAI | Substantially Equivalent | Depuy Mitek, A Johnson & Johnson Company | accessdata.fda.gov |
| April 3, 2015 | K143475 | VAPR Tripolar Suction Electrode | GEI | Substantially Equivalent | Depuy Mitek | accessdata.fda.gov |
| October 24, 2014 | K142574 | 4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 6.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, | MBI | Substantially Equivalent | Depuy Mitek, A Johnson & Johnson Company | accessdata.fda.gov |
| August 5, 2014 | K140896 | VAPR ARCTIC SUCTION ELECTRODE | GEI | Substantially Equivalent | Depuy Mitek, A Johnson & Johnson Company | accessdata.fda.gov |
| July 8, 2014 | K140643 | GRYPHON BR ANCHOR W/PROKNOT TECHNOLOGY,GRYPHON PEEK ANCHOR W/ PROKNOT TECHNOLOGY | MAI | Substantially Equivalent | Depuy Mitek, A Johnson and Johnson Company | accessdata.fda.gov |
| July 7, 2014 | K140324 | RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT: STANDARD, LONG AND XL | MBI | Substantially Equivalent | Depuy Mitek, A Johnson and Johnson Company | accessdata.fda.gov |
| June 10, 2014 | K141259 | GRYPHON BR ANCHOR WITH PERMACORD, GRYPHON BR DS ANCHOR WITH PERMACORD,GRYPHON PEEK ANCHOR WITH PERMACORD, GRYPHON PEEK | MAI | Substantially Equivalent | Depuy Mitek, A Johnson & Johnson Company | accessdata.fda.gov |
| April 3, 2014 | K133834 | DEPUY GLOBAL UNITE SHOULDER SYSTEM | KWS | Substantially Equivalent | Depuy(Ireland) | accessdata.fda.gov |
| February 4, 2014 | K133794 | 4.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 STRANDS OF #2 PERMACORD SUTURE, 5.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 | MAI | Substantially Equivalent | Depuy Mitek, A Johnson & Johnson Company | accessdata.fda.gov |
| November 5, 2013 | K132241 | GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY, GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY - HIP, GRYPHON PEEK ANCHOR W/ PROKNOT T | MAI | Substantially Equivalent | Depuy Mitek, A Johnson & Johnson Company | accessdata.fda.gov |
| August 1, 2013 | K130814 | RIGIDLOOP FIXATION DEVICE (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MM | MBI | Substantially Equivalent | Depuy Mitek, A Johnson & Johnson Company | accessdata.fda.gov |
| July 25, 2013 | K131974 | HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM) | MAI | Substantially Equivalent | Depuy Mitek, A Johnson & Johnson Company | accessdata.fda.gov |
| July 22, 2013 | K131191 | 4MM & 5MM FULL RADIUS BLADE PLUS, 4MM & 5MM BARREL BUR PLUS/4MM BARREL TORNADO BUR PLUS, 4MM & 5MM AGGRESSIVE BLADE PLUS | HRX | Substantially Equivalent | Depuy Mitek, A Johnson & Johnson Company | accessdata.fda.gov |
| June 27, 2013 | K131683 | HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM) | MBI | Substantially Equivalent | Depuy Mitek, Inc., A Johnson and Johnson Company | accessdata.fda.gov |
| June 14, 2013 | K130912 | OMNICUT RESECTION BLADE | HRX | Substantially Equivalent | Depuy Mitek, A Johnson & Johnson Company | accessdata.fda.gov |
| May 24, 2013 | K130917 | HEALIX ADVANCE KNOTLESS BR ANCHOR | MAI | Substantially Equivalent | Depuy Mitek, A Johnson & Johnson Company | accessdata.fda.gov |
| May 21, 2013 | K130539 | HEALIX ADVANCE KNOTLESS PEEK ANCHOR (4.75MM)(5.5MM) | MBI | Substantially Equivalent | Depuy Mitek, A Johnson & Johnson Company | accessdata.fda.gov |
| May 17, 2013 | K130105 | RIGIDFIX CURVE ST ACL PLA CROSS PIN SYSTEM, RIGIDFIX CURVE ST ACL PEEK CROSS PIN SYSTEM | HTY | Substantially Equivalent | Depuy Mitek, A Johnson & Johnson Company | accessdata.fda.gov |
| May 1, 2013 | K130169 | FMS VUE FLUID MANAGMENT SYSTEM, FMS CONNECT INTERFACE CABLE | HRX | Substantially Equivalent | Depuy Mitek, A Johnson & Johnson Company | accessdata.fda.gov |
| February 26, 2013 | K123668 | ORTHOCORD | NEW | Substantially Equivalent | Depuy Mitek, Inc., A Johnson and Johnson Company | accessdata.fda.gov |
| February 1, 2013 | K123362 | MILAGRO ADVANCE INTERFERENCE SCREW | HWC | Substantially Equivalent | Depuy Mitek, A Johnson & Johnson Company | accessdata.fda.gov |
| December 19, 2012 | K123359 | OVS1 VIDEO SYSTEM | FCW | Substantially Equivalent | Olive Medical Corp. | accessdata.fda.gov |
| December 13, 2012 | K122869 | MILAGRO INTERFERENCE SCREWS | MAI | Substantially Equivalent | Depuy Mitek, A Johnson & Johnson Company | accessdata.fda.gov |
| November 5, 2012 | K122425 | VAPR P50 SUCTION ELECTRODE VAPR S90 SUCTION ELECTRODE VAPR P50 SUCTION ELECTRODE WITH HANDCONTROLS VAPRS90 SUCTION ELECT | GEI | Substantially Equivalent | Depuy Mitek, A Johnson & Johnson Company | accessdata.fda.gov |
| October 31, 2012 | K122395 | DEPUY AGILITY LP TOTAL ANKLE PROSTHESIS | HSN | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| October 2, 2012 | K122123 | 6-8MM X 30 MM INTRAFIX PEEK TAPERED SCREW 7-9MM X 30MM INTRAFIX PEEK TAPERED SCREW 8-10MM X 30 MM INTRAFIX PEEK TAPERED | MBI | Substantially Equivalent | Depuy Mitek, Inc., A Johnson and Johnson Company | accessdata.fda.gov |
| September 6, 2012 | K122442 | DEPUY CTA REVERSE SHOULDER SYSTEM | PHX | Substantially Equivalent | Depuy France | accessdata.fda.gov |
| June 11, 2012 | K120174 | DEPUT DELTA XTEND REVERSE SHOULDER | PHX | Substantially Equivalent | Depuy France | accessdata.fda.gov |
| May 11, 2012 | K120449 | HEALIX ADVANCE PEEK ANCHOR | HWC | Substantially Equivalent | Depuy Mitek | accessdata.fda.gov |
| April 24, 2012 | K120589 | MILAGRO INTERFERENCE SCREWS | MAI | Substantially Equivalent | Depuy Mitek, A Johnson & Johnson Company | accessdata.fda.gov |
| April 6, 2012 | K120095 | SIDE EFFECT WITH HAND CONTROLS, HOOK ELECTRODE WITH HAND CONTROLS, 2.3 WEDGE ELECTRODE WITH HAND CONTROLS, S90 WITH HAND | GEI | Substantially Equivalent | Depuy Mitek, A Johnson & Johnson Company | accessdata.fda.gov |
| February 29, 2012 | K120078 | HEALIX ADVANCE BR ANCHOR | MAI | Substantially Equivalent | Depuy Mitek Inc., Johnson and Johnson Company | accessdata.fda.gov |
| February 27, 2012 | K113545 | VAPR VUE GENERATOR, VAPR 3 ELECTROSURGICAL SYSTEM, VAPR II ELECTROSURGICAL SYSTEM COOLPLUSE 90 AND COOLPLUSE 90 WITH HAN | GEI | Substantially Equivalent | Depuy Mitek, A Johnson & Johnson Company | accessdata.fda.gov |
| December 20, 2011 | K113534 | HEALIX KNOTLESS ANCHOR | MAI | Substantially Equivalent | Depuy Mitek, A Johnson & Johnson Company | accessdata.fda.gov |
| October 25, 2011 | K112249 | HEALIX KNOTLESS(TM) ANCHOR | MAI | Substantially Equivalent | Depuy Mitek, A Johnson & Johnson Company | accessdata.fda.gov |
| July 21, 2011 | K103831 | DEPUY MITEK MILAGRO INTERFERENCE SCREW MODEL 231803, 231804, 231807, 231809 | MAI | Substantially Equivalent | Depuy Mitek, A Johnson & Johnson Company | accessdata.fda.gov |
| April 11, 2011 | K110763 | LATARJET CORTICAL SCREW SET | HWC | Substantially Equivalent | T.A.G. Medical Products Corporation, Ltd. | accessdata.fda.gov |
| March 11, 2011 | K103712 | GRYPHON PEEK DS ANCHOR W/ ORTHOCORD, GRYPHON PEEK ANCHOR W/ ORTHOCORD | HWC | Substantially Equivalent | Depuy Mitek, A Johnson & Johnson Company | accessdata.fda.gov |
| January 7, 2011 | K102298 | TRANSTEND BR ANCHOR W/ ORTHOCORD, TRANSTEND TI ANCHOR W/ORTHOCORD, TRANSTEND PEEK ANCHOR W/ORTHOCORD, HEALIX TRANSTEND | HWC | Substantially Equivalent | Depuy Mitek, A Johnson & Johnson Company | accessdata.fda.gov |
| December 15, 2010 | K101996 | DEPUY GLOBAL UNITE SHOULDER SYSTEM | PHX | Substantially Equivalent | Depuy(Ireland) | accessdata.fda.gov |
| October 20, 2010 | K102443 | INTRAFIX TIBIAL SHEATH | MBI | Substantially Equivalent | Depuy Mitek, A Johnson & Johnson Company | accessdata.fda.gov |
| June 18, 2010 | K100638 | VAPR VUE RADIOFREQUENCY SYSTEM ,MODEL 225024, VPR VUE WIRELESS FOOTSWITCH, MODEL 227214 | GEI | Substantially Equivalent | Depuy Mitek, A Johnson & Johnson Company | accessdata.fda.gov |
| April 30, 2010 | K100012 | GRYPHON T BR DS ANCHOR W/ORTHOCORD, GRYPHON T BR ANCHOR W /ORTHOCORD, GRYPHON P BR DS ANCHOR W/ORTHOCORD, GRYPHON P BR A | MAI | Substantially Equivalent | Depuy Mitek, A Johnson & Johnson Company | accessdata.fda.gov |
| March 17, 2010 | K100532 | VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 210819 | HWC | Substantially Equivalent | Depuy Mitek, A Johnson & Johnson Company | accessdata.fda.gov |
| February 4, 2010 | K092836 | OMNISPAN MENISCAL REPAIR SYSTEM/0 DEGREE, MODEL 228140, RAPIDLOC A2 MENISCAL REPAIR SYSTEM/12 DEGREE, MODEL 228141 | MBI | Substantially Equivalent | Depuy Mitek, A Johnson & Johnson Company | accessdata.fda.gov |
| August 7, 2009 | K091041 | RIGIDFIX BIOCRYL 2.7MM BTB (210815), FEMORAL 3.3MM ST (210816), AND TIBIAL 3.3MM ST (210817) CROSS PIN KITS | MAI | Substantially Equivalent | Depuy Mitek, A Johnson & Johnson Company | accessdata.fda.gov |
| July 27, 2009 | K092122 | GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID | KWS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| July 14, 2009 | K091751 | DEPUY DELTA XTEND REVERSE SHOULDER XLK CUP | KWS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| July 7, 2009 | K091694 | MODIFICATION TO:LATARJET CORTICAL SCREW SET, MODELS 523JT, 523J (36-48MM) | HWC | Substantially Equivalent | Tag Medical Products | accessdata.fda.gov |
| April 17, 2009 | K083096 | LATARJET CORTICAL SCREW SET | HWC | Substantially Equivalent | Tag Medical Products | accessdata.fda.gov |
| April 3, 2009 | K090669 | RIGIDFIX BIOCRYL CROSS PIN KITS | MAI | Substantially Equivalent | Depuy Mitek, A Johnson & Johnson Company | accessdata.fda.gov |
| March 11, 2009 | K090124 | GRYPHON P BR DS ANCHOR W/ORTHOCORD,GRYPHON P BR ANCHOR W/ORTHOCORD, MODEL 210813,210814 | MAI | Substantially Equivalent | Depuy Mitek, A Johnson & Johnson Company | accessdata.fda.gov |
| February 9, 2009 | K083107 | MODIFICATION TO DEPUY NEUFLEX PIP FINGER | KYJ | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| December 19, 2008 | K082643 | 3.5 MM SIDE EFFECT ELECTRODE WITH INTEGRATED HANDPIECE, MODEL 227301, 3.5 MM ANGLED SIDE EFFECT ELECTRODE WITH INTEGRATE | GEI | Substantially Equivalent | Depuy Mitek, A Johnson & Johnson Company | accessdata.fda.gov |
| December 18, 2008 | K082715 | DEPUY GLOBAL AP CTA HUMERAL HEAD | HSD | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| November 7, 2008 | K082282 | HEALIX TI ANCHOR | HWC | Substantially Equivalent | Depuy Mitek, A Johnson & Johnson Co. | accessdata.fda.gov |
| August 8, 2008 | K080990 | DEPUY GLOBAL C.AP. CTA RESURFACING SHOULDER | HSD | Substantially Equivalent | DePuy Orthopaedics, 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 |
|---|---|---|---|---|---|---|
| February 24, 2025 | 96347 | Class II | Ongoing | COR Disposable Kit, 8 mm. Cartilage Transplant System. | Device is missing the pin in the graft loader component. | accessdata.fda.gov |
| April 13, 2023 | 92210 | Class II | Ongoing | DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212724 | IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time | accessdata.fda.gov |
| November 4, 2019 | 84237 | Class II | Terminated | Healix Knotless ADV BR 4.75 Suture Anchor | Specific product codes and lots of the Mitek HEALIX ADVANCE" Knotless Anchors were manufactured with BIOCRYL" Biocomposite Material instead of BIOCRYL RAPIDE Biocomposite Material. BIOCRYL and BIOCRYL RAPIDE are biocompatible and effective material choices for absorbable, injection-molded sports medicine implant fixation. | accessdata.fda.gov |
| August 30, 2018 | 81059 | Class II | Terminated | Mitek Screw and Washer Depth Gauge, Product Code 219024 | The device has an offset in the design that results in a reading approximately 3.2mm shorter than the actual length of the bone hole. | accessdata.fda.gov |
| December 22, 2017 | 79518 | Class II | Terminated | LATARJET EXPERIENCE Sharp Curved Ostetome Product Usage: The Latarjet EXPERIENCE Instability Shoulder Set is intended to provide to the orthopedic surgeon with a means of bone fixation and to assist in the management of | Reports of product loosening or coming unscrewed from the handle. | accessdata.fda.gov |
| August 31, 2017 | 79117 | Class II | Terminated | 1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set is intended to deliver irrigation fluid from irrigation containers to the operative site during arthroscopic procedures. | Leakage of FMS gravity tub sets (281113) at the bulb and tube connection | accessdata.fda.gov |
| May 12, 2017 | 77252 | Class II | Terminated | DePuy Mitek LATARJET EXPERIENCE-Combo Screw Driver Product Code: 288211 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a b | Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw | accessdata.fda.gov |
| November 23, 2015 | 72703 | Class II | Terminated | VAPR TRIPOLAR 90" Degree Suction Electrodes (Model/Catalog No: 225028) | Mitek identified that on VAPR Tripolar 90 Degree Suction Electrode the ablation and coagulation buttons are colored incorrectly. The wiring for each button function was confirmed as correct and the non-conformance impacted button color only | accessdata.fda.gov |
| November 20, 2015 | 72697 | Class II | Terminated | FMS neXtra 3.5mm Full Radius Cutter Shaver Blades; Product Code: 283305 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures. | Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label. | accessdata.fda.gov |
| August 29, 2013 | 66145 | Class II | Terminated | DePuy Mitek FMS Intermediary Tubing with One-Way valve Product Code: 281142 Product Usage: The Intermediary Tubing for FMS Fluid Management Systems connects the Inflow Tubing to the arthroscopic sheath during arthroscopi | Pillow valve included in the FMS Duo outflow tubing set and the FMS Solo intermediary tubing set may not perform as intended. may result in backflow of irrigation fluid into the One Day Set which may potentially lead to patient cross-contamination | accessdata.fda.gov |
| April 15, 2013 | 64913 | Class II | Terminated | DePuy Mitek Tissue Liberator -Blade Up Catalog Number: 214623 The Reusable Arthroscopy Instruments are reusable, non-powered surgical instruments used during arthroscopic surgery of any joint except the spine. | Labeled incorrectly as a Blade Up configuration instead of a Blade Down configuration. | accessdata.fda.gov |
| March 22, 2013 | 64706 | Class II | Terminated | ORTHOCORD BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223111. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures. | The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. While this statement is true for Violet ORTHOCORD sutures, it is an inaccurate statement for Blue ORTHOCORD free strand sutures. Based on in-vivo strength retention study, a Blue ORTHOCORD sutures mainta | accessdata.fda.gov |
| November 16, 2012 | 63732 | Class II | Terminated | DePuy Mitek 11 MM Fully Fluted Reamer, Sterile Product Number: 232423 DePuy Mitek Sterile Reamers are intended to cut through cortical and cancellous bone during Cruciate Ligament Repair/Reconstruction of the knee. | Specific units of the DePuy Mitek Sterile Reamers are not labeled correctly, 7 units were labeled as 11MM while the box actually contained a 10 MM reamer | accessdata.fda.gov |
| September 6, 2012 | 63121 | Class II | Terminated | SpiraLok 5.0mm with Ethibond and needles Product Number: 222960 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee | Fracture of SPIRALOK Anchors post op, requiring patient revision | accessdata.fda.gov |
| May 4, 2012 | 61874 | Class II | Terminated | Depuy Spine Side Fire Needles 13G X 6IN, part of the Confidence Spinal Cement System Product Code 283904613. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired locatio | Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles | accessdata.fda.gov |
| March 12, 2012 | 63283 | Class II | Terminated | DePuy Mitek VAPR Hook Electrode 3.5mm Hook Electrode with Integrated Handpiece Catalog Number: 227305 The DePuy Mitek VAPR Electrodes for use with the VAPR Radiofrequency System are intended for resection, ablation, exci | Product may have wrong large product identification label with symbols on the box indicating a S90 VAPR Electrode instead of the VAPR 3.5 hook electrode | accessdata.fda.gov |
| January 27, 2012 | 61088 | Not yet classified | Terminated | Depuy Mitek Lupine (Panalok) Loop Arthro #2 Ethibond Catalog Number: 210704 The Lupine Anchor System is indicated for use in soft tissue bone fixation. | Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair | accessdata.fda.gov |
| October 31, 2011 | 60287 | Not yet classified | Terminated | DePuy Mitek Panalock Loop, Lupine Anchor Catalog #210704 The LUPINE BR Anchor System is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization. | Incorrect suture configuration | accessdata.fda.gov |
| June 27, 2011 | 59229 | Not yet classified | Terminated | Depuy Mitek Ratchet Handle with Quick Connect Product code: 219970. Instrument used with anchor inserters for insertion of DePuy Mitek Interference Screws (orthopedic). | Quick Disconnect Ratchet Handle may slip up the driver shaft or disengage leaving the shaft in the screw head. | accessdata.fda.gov |
| February 24, 2011 | 58037 | Not yet classified | Terminated | DePuy Mitek GRYPHON T BR DS Anchor w/ORTHOCORD Product Code: 210811 Gryphon BR Suture Anchors are intended for: Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separa | Metal debris in the shaft component of the device | accessdata.fda.gov |
| December 3, 2010 | 57385 | Not yet classified | Terminated | DePuy Mitek FMS Irrigation Intermediary Tube With One-way Valve Arthroscopy tubing Product Code: 281142 Fluid Tissue Management | Product sterility may be compromised due to breach in sterile packaging | accessdata.fda.gov |
| June 7, 2010 | 55877 | Not yet classified | Terminated | Mitek VAPR S90 Suction Electrode (integrated) Product Code: 225370 The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction Electrodes (S9 and S ) with | Product does not meet the required packaging specifications for pouch seal integrity which could lead to a breach in sterility | accessdata.fda.gov |
| April 29, 2008 | 47897 | Not yet classified | Terminated | Lupine BR Anchor w/Orthocord TCP/PLGA Absorbable Anchor, size 2 (5 metric) Braided Composite Suture, violet 36" (91cm) Size 2 (5metric) eyelet loop. Made in Switzerland; Sterile. The Lupine BR Anchor System is indicated | Lupine BR Anchor w/Orthocord was assembled with an incorrect suture configuration. The suture loop was not assembled at the distal end of the anchor. It was only threaded through the suture hole in the anchor. Risk associated with incorrect suture configuration include premature breakage. | accessdata.fda.gov |
| February 17, 2006 | 34684 | Not yet classified | Terminated | Depuy Mitek Bioknotless Anchor with Ethibond Suture Ref No. 212728 | The inserter shafts bend, as they were manufactured with a different stainless steel than specified. | accessdata.fda.gov |
| October 27, 2005 | 33990 | Not yet classified | Terminated | Depuy Mitek Fastin RC Anchor with Panacryl (2) strands Size 2 Panacryl Poly ***braided absorbable suture Reference Number: 222740 | The device may contain one strand of suture instead of two strands | accessdata.fda.gov |
| August 9, 2005 | 32951 | Not yet classified | Terminated | DePuy Mitek Straightshot Ligament Graft Passer/Protector, 11.5 mm Catalog Number : 232220 | Mislabeled: The kit contained the incorrect Ligament Passer. The package contained a 9.5 mm instead of the labeled 11.5mm ligament passer | accessdata.fda.gov |
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Updated February 26, 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.