Recall Z-0459-2021 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Exactech, Inc.
Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium
| Date | Oct 6, 2020 |
| Status | Terminated |
| Reason | The product may be mislabeled. |
| Root cause | Packaging process control |
| Action | Exactech distributed the recall notice to consignees in possession of affected inventory worldwide on 10/06/2020. Consignees have been instructed to: -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 Inventory Response Form to Exactech. |
| Quantity | 69 devices |
| Distribution | US consignees - AZ, CA, CO, FL, IL, IN, KY, LA, OH, OK, MD, ME, MN, NV, NY, SC, TN, TX, VA, WA, WI International consignees - Australia, Japan, and United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113309 | EXACTECH EQUINOXE CAGE GLENOIDS Exactech, Inc., Dec 8, 2011 |