Recall Z-2562-2025 · PHX Shoulder Prosthesis, Reverse Configuration
Exactech, Inc.
Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG PE 38MM HUM LINER +2.5), REF:322-42-00 (145-DEG PE 42MM HUM LINER +0), REF: 322-42-03 (145-DEG PE 42MM HUM LINER +2.5)
| Date | Sep 12, 2025 (initiated Aug 15, 2025) |
| Status | Open, Classified |
| Reason | Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling. |
| Root cause | Process design |
| Action | On August 15, 2025, Exactech, Inc. initiated a "Urgent Voluntary Medical Device Recall". Exactech asked consignees to take the following actions: 1. Healthcare providers who have treated patients using the Exactech Equinoxe Humeral Liners subject to this recall should continue to follow those patients pursuant to the healthcare provider s standard of care. 2. Do Not Use / Quarantine any of these products in your inventory. 3. Segregate and return unused units via prepaid packaging to Exactech. 4. Complete the Recall Confirmation Form confirming product return or on-hand inventory. 5. Trans |
| Quantity | 11,542 units |
| Distribution | Worldwide - US Nationwide distribution in the states of CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MN, NV, NY, OH, OK, PR, SC, TN, TX, VA, WI and the countries of Australia, Austria, Brazil, Canada, Colombia, France, United Kingdom, Guatemala, India, Italy, Japan, Korea, Germany, The Ne |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K223833 | Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays Exactech, Inc., Sep 14, 2023 |