DePuy Mitek, Inc., A Johnson & Johnson Co. FDA Record
DePuy Mitek, Inc., A Johnson & Johnson Co. has 51 FDA recalls, 2 inspections, 3 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "DePuy Mitek, Inc., A Johnson & Johnson Co." is on file.
- Latest recall
- Z-1315-2025 · Class II · Feb 24, 2025
- Latest inspection
- Mar 6, 2013 · NAI
- Latest 510(k)
- Jun 27, 2013
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 51 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 3 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 2 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 2 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 5 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 2 | 0 |
| 2018 | 0 | 0 | 0 | 1 | 0 |
| 2017 | 0 | 0 | 0 | 7 | 0 |
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Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1315-2025 | Class II | COR Disposable Kit, 8 mm w/ Perpendicularity. Cartilage Transplant System. | Feb 24, 2025 |
| Z-1314-2025 | Class II | COR Disposable Kit, 8 mm. Cartilage Transplant System. | Feb 24, 2025 |
| Z-1680-2023 | Class II | DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association… | Apr 13, 2023 |
| Z-1681-2023 | Class II | DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fixation in… | Apr 13, 2023 |
| Z-1679-2023 | Class II | DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association… | Apr 13, 2023 |
| Z-1678-2023 | Class II | DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in… | Apr 13, 2023 |
| Z-1677-2023 | Class II | DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in… | Apr 13, 2023 |
| Z-0665-2020 | Class II | Healix Knotless ADV BR 4.75 Suture Anchor | Nov 4, 2019 |
| Z-0666-2020 | Class II | Healix Knotless ADV BR 5.5 Suture Anchor | Nov 4, 2019 |
| Z-0208-2019 | Class II | Mitek Screw and Washer Depth Gauge, Product Code 219024 | Aug 30, 2018 |
| Z-1749-2018 | Class II | LATARJET EXPERIENCE Sharp Curved Ostetome Product Usage: The Latarjet EXPERIENCE Instability… | Dec 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… | Aug 31, 2017 |
| Z-2618-2017 | Class II | DePuy Mitek LATARJET EXPERIENCE Top Hat Tap Product Code: 288203 Product Usage: The Latarjet… | May 12, 2017 |
| Z-2617-2017 | Class II | DePuy Mitek LATARJET EXPERIENCE Coracoid Top Hat Drill Product Code: 288202 Product Usage: The… | May 12, 2017 |
| Z-2616-2017 | Class II | DePuy Mitek LATARJET EXPERIENCE Coracoid Drill Product Code: 288201 Product Usage: The Latarjet… | May 12, 2017 |
| Z-2619-2017 | Class II | DePuy Mitek LATARJET EXPERIENCE Extraction Driver Product Code: 288216 Product Usage: The… | May 12, 2017 |
| Z-2615-2017 | Class II | DePuy Mitek LATARJET EXPERIENCE-Combo Screw Driver Product Code: 288211 Product Usage: The… | May 12, 2017 |
| Z-0479-2016 | Class II | VAPR¿ TRIPOLAR 90" Degree Suction Electrodes (Model/Catalog No: 225028) | Nov 23, 2015 |
| Z-0658-2016 | Class II | FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades; Product Code: 287325 Intended to provide… | Nov 20, 2015 |
| Z-0657-2016 | Class II | FMS neXtra¿ 3.5mm Aggressive Cutter Shaver Blades; Product Code: 283315 Intended to provide… | Nov 20, 2015 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 6, 2013 | Norwood, MA | Devices | No Action Indicated (NAI) | 1221934 |
| Oct 22, 2009 | Norwood, MA | Devices | Voluntary Action Indicated (VAI) | 1221934 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 1221934 | Norwood, MA | 2 | Mar 6, 2013 |
DePuy Mitek, Inc., A Johnson & Johnson Co. and the FDA: common questions
Has DePuy Mitek, Inc., A Johnson & Johnson Co. received an FDA warning letter?
No FDA warning letter addressed to the name "DePuy Mitek, Inc., A Johnson & Johnson Co." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has DePuy Mitek, Inc., A Johnson & Johnson Co. received an FDA Form 483?
FDA has not published a Form 483 for "DePuy Mitek, Inc., A Johnson & Johnson Co." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect DePuy Mitek, Inc., A Johnson & Johnson Co.?
The most recent FDA inspection on file ended Mar 6, 2013 at Norwood, MA and was classified NAI. FDA has 2 inspections of DePuy Mitek, Inc., A Johnson & Johnson Co. on file.
Has DePuy Mitek, Inc., A Johnson & Johnson Co. had an FDA recall?
Yes. DePuy Mitek, Inc., A Johnson & Johnson Co. has 51 FDA recalls on record. The most recent started Feb 24, 2025.
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