DePuy Mitek, Inc., a Johnson & Johnson Co.
FDA Regulatory Profile
Summary
- Total Recalls
- 51
- 510(k) Clearances
- 3
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1315-2025 | Class II | COR Disposable Kit, 8 mm w/ Perpendicularity. Cartilage Transplant System. | February 24, 2025 |
| Z-1314-2025 | Class II | COR Disposable Kit, 8 mm. Cartilage Transplant System. | February 24, 2025 |
| Z-1677-2023 | Class II | DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in assoc | April 13, 2023 |
| Z-1681-2023 | Class II | DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fixation in associatio | April 13, 2023 |
| Z-1678-2023 | Class II | DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in associ | April 13, 2023 |
| Z-1680-2023 | Class II | DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association | April 13, 2023 |
| Z-1679-2023 | Class II | DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association | April 13, 2023 |
| Z-0666-2020 | Class II | Healix Knotless ADV BR 5.5 Suture Anchor | November 4, 2019 |
| Z-0665-2020 | Class II | Healix Knotless ADV BR 4.75 Suture Anchor | November 4, 2019 |
| Z-0208-2019 | Class II | Mitek Screw and Washer Depth Gauge, Product Code 219024 | August 30, 2018 |
| Z-1749-2018 | Class II | LATARJET EXPERIENCE Sharp Curved Ostetome Product Usage: The Latarjet EXPERIENCE Instability Sho | December 22, 2017 |
| Z-0695-2018 | Class II | 1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set is intended to deliver i | August 31, 2017 |
| Z-2618-2017 | Class II | DePuy Mitek LATARJET EXPERIENCE Top Hat Tap Product Code: 288203 Product Usage: The Latarjet Cor | May 12, 2017 |
| Z-2616-2017 | Class II | DePuy Mitek LATARJET EXPERIENCE Coracoid Drill Product Code: 288201 Product Usage: The Latarjet C | May 12, 2017 |
| Z-2617-2017 | Class II | DePuy Mitek LATARJET EXPERIENCE Coracoid Top Hat Drill Product Code: 288202 Product Usage: The La | May 12, 2017 |
| Z-2615-2017 | Class II | DePuy Mitek LATARJET EXPERIENCE-Combo Screw Driver Product Code: 288211 Product Usage: The Lata | May 12, 2017 |
| Z-2619-2017 | Class II | DePuy Mitek LATARJET EXPERIENCE Extraction Driver Product Code: 288216 Product Usage: The Latarj | May 12, 2017 |
| Z-0479-2016 | Class II | VAPR¿ TRIPOLAR 90" Degree Suction Electrodes (Model/Catalog No: 225028) | November 23, 2015 |
| Z-0658-2016 | Class II | FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades; Product Code: 287325 Intended to provide control | November 20, 2015 |
| Z-0656-2016 | Class II | FMS neXtra¿ 3.5mm Full Radius Cutter Shaver Blades; Product Code: 283305 Intended to provide con | November 20, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K131683 | HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM) | June 27, 2013 |
| K123668 | ORTHOCORD | February 26, 2013 |
| K122123 | 6-8MM X 30 MM INTRAFIX PEEK TAPERED SCREW 7-9MM X 30MM INTRAFIX PEEK TAPERED SCREW 8-10MM X 30 MM IN | October 2, 2012 |