Recall Z-0884-2021 ยท HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Exactech, Inc.
Equinoxe Humeral Stem, Primary, Press Fit, 11mm
| Date | Nov 9, 2020 |
| Status | Open, Classified |
| Reason | Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package. |
| Root cause | Employee error |
| Action | Exactech distributed the recall notice titled, "URGENT PRODUCT RECALL NOTICE" to consignees in possession of affected inventory in the US and Australia on November 9, 2020 via email. In order to comply with the notice, 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 | 14 devices |
| Distribution | Distributed within the US to KS, OH, CA. International distribution to Australia and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042021 | EXACTECH EQUINOXE SHOULDER SYSTEM Exactech, Inc., Oct 26, 2004 |