Recall Z-0012-2019 ยท KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Exactech, Inc.
Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery
| Date | Aug 21, 2018 |
| Status | Open, Classified |
| Reason | The Equinoxe Reverse Drill Bit Kits may contain two 2mm diameter drill bits instead of one 2mm diameter drill bit and one 3.2mm diameter drill bit as intended. |
| Root cause | Under Investigation by firm |
| Action | The firm disseminated the field safety notice by email on 08/21/2018. The notice requested the following actions: " Immediately cease distribution or use of this product. " Extend the information to their accounts that may have this product in their possession. " Identify and quarantine any of the subject devices in their inventory " Complete and return the attached Recall Acknowledgment Form and Recall Inventory Response Form to Exactech. |
| Quantity | 2 units |
| Distribution | In the countries of Australia and France |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063569 | EQUINOXE REVERSE SHOULDER SYSTEM Exactech, Inc., Feb 23, 2007 |