Reported Sep 24, 2025 · Ongoing
Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG…
Exactech, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Exactech, Inc. · 2320 Nw 66th Ct · Gainesville, FL · 32653-1630
Is this the product you have?
3 of 3 products
| Model / number | Product as published |
|---|---|
322-38-03 | (145-DEG PE 38MM HUM LINER +2.5) |
322-42-00 | (145-DEG PE 42MM HUM LINER +0) |
322-42-03 | (145-DEG PE 42MM HUM LINER +2.5) |
- Lot codes and dates
- All Serial Numbers
- REF322-38-00/UDI:10885862593832
- REF322-38-03/UDI:10885862593849
- REF322-42-00/UDI: 10885862593917
- REF322-42-03/UDI:10885862593924
- Amount recalled
- 11,542 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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