Recall Z-0731-2020 ยท HTW Bit, Drill
AAP Implantate Ag
INTEGRA, Drill CS 4.5, quick coupling single use, REF 430453
| Date | Jan 25, 2019 |
| Status | Terminated |
| Reason | Products were distributed with the incorrect instructions for use. |
| Root cause | Other |
| Action | The firm notified its sole consignee about the labeling issue by email on 01/25/2019 and provided the correct instructions for use. |
| Quantity | 2 units |
| Distribution | Texas |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.