Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG PE
FDA device recall Z-2562-2025 · posted 2025-09-12 · Open, Classified
Recall details
- Recalling firm
- Exactech, Inc.
- Reason for recall
- Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
- Action taken
- 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. Transmission of this Recall Notice: This notice must be passed on to all who need to be aware within your organization and any locations the affected products has been transferred to. This recall has been reported to the U.S. FDA and will be reported to other regulatory authorities as required.
- Root cause
- Process design
- Status
- Open, Classified
- Product code
- PHX
- Quantity affected
- 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, Braz
- Date initiated
- 2025-08-15
- Date posted
- 2025-09-12
- Location
- Gainesville, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays (K223833) | Exactech, Inc. | 2023-09-14 |