Shoulder humeral liners recalled over articular surface outside dimensional specification
Exactech Equinoxe Reverse Shoulder humeral liners in 38 mm and 42 mm sizes are recalled because the articular surface position falls outside the dimensional specification in the labeling. 11,542 units are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; an implant outside its dimensional specification is a potential harm and no injuries are reported.
Plain-English summary
Exactech Equinoxe Reverse Shoulder humeral liners are being recalled under REF 322-38-00, 322-38-03, 322-42-00 and 322-42-03, covering the 145-degree polyethylene 38 mm and 42 mm liners at +0 and +2.5, across all serial numbers. The recall covers 11,542 units distributed across many states and internationally.
The reverse shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling. The FDA classified the action as Class II.
Hospitals and surgical centres holding these REF numbers should quarantine affected stock and follow the manufacturer's instructions for return. Patients with an implanted liner who have questions should speak to their surgeon.
The recalled product
- Product
- 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)
- Manufacturer
- Exactech, Inc.
- Affected units
- 11,542
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- All Serial Numbers
- REF: 322-38-00/UDI:10885862593832
- REF: 322-38-03/UDI:10885862593849
- REF: 322-42-00/UDI: 10885862593917
- REF:322-42-03/UDI:10885862593924
Distribution
Part of a larger recall action
This product is one of 2 recalled by Exactech, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Exactech, Inc.
See all →- HighExactech Ergo modular impactor handle may be missing its cross-pin
FDA (Devices) · 2026-03-18
- HighExactech Equinoxe core instrument kits may have handles missing cross-pins
FDA (Devices) · 2026-03-18
- ModeratePilot tip converters recalled after release without completed performance testing
FDA (Devices) · 2025-11-26
- ModerateShoulder reamers recalled after release without completed performance testing
FDA (Devices) · 2025-11-26
- ModerateShoulder reamer 46mm recalled after release without completed performance testing
FDA (Devices) · 2025-11-26
Same hazard · dimensional specification
See all →- HighReverse shoulder liners recalled over articular surface outside dimensional specification
FDA (Devices) · 2025-09-24