Device recall
Z-1680-2023: DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone…
FDA device recall · Class II · DePuy Mitek, Inc., a Johnson & Johnson Co.
Key facts
| Recall number (Z-number) | Z-1680-2023 |
|---|---|
| Recall event | 92210 |
| Product | DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212722 |
| Product code | MAI |
| Recalling firm | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K040827, K062170, K070925, K150209 |
| FEI number | 1221934 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database