Reverse shoulder liners recalled over articular surface outside dimensional specification
Exactech Equinoxe Reverse Shoulder humeral liners under REF 320-38 and 320-42 are recalled because the articular surface position falls outside the dimensional specification in the labeling. 61,334 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 320-38-00, 320-38-03, 320-42-00 and 320-42-03, covering the 145-degree polyethylene 38 mm and 42 mm liners at +0 and +2.5, across all serial numbers. The recall covers 61,334 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, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38MM HUM LINER +2.5/ 320-42-00,145-DEG PE 42MM HUM LINER +0/ 320-42-03,145-DEG PE 42MM HUM LINER +2.5/
- Manufacturer
- Exactech, Inc.
- Affected units
- 61,334
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 (1)
- All Serial Numbers
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.
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Same hazard · dimensional specification
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FDA (Devices) · 2025-09-24