Exactech Equinoxe Reverse Shoulder Implant Liners Recalled for Oxygen Barrier Packaging Defect
Exactech recalls 3,648 reverse shoulder implant liners due to nonconforming packaging. Vacuum bags lack required oxygen barrier (EVOH) protection against material degradation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Class II recall with packaging specification deficiency and no mentioned adverse events. Hazard is theoretical—potential oxidative degradation of implant material due to missing oxygen barrier—consistent with precautionary recalls.
Plain-English summary
Exactech, Inc. is recalling 3,648 units of Equinoxe REVERSE SHOULDER 42mm Constrained Humeral Liner implants (Item Numbers 320-42-10 and 320-42-13) due to nonconforming packaging.
The affected units were packaged in vacuum bags that do not meet the established packaging specification. Specifically, the bags lack an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). The absence of this barrier could allow oxygen exposure that may contribute to oxidative degradation of the ultra-high molecular weight polyethylene (UHMWPE) material, potentially affecting device performance over time.
The recalled implants were distributed nationwide in the United States and internationally to 30 countries including Australia, Canada, China, France, Germany, Japan, South Korea, and the United Kingdom. Healthcare providers should verify affected units by serial number and contact Exactech for replacement or instructions.
No adverse events are mentioned in the recall notice. Healthcare facilities and patients with concerns should contact their healthcare provider or Exactech for guidance.
The recalled product
- Product
- Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
- Manufacturer
- Exactech, Inc.
- Affected units
- 3,648
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 (20)
- a) Item number 320-42-10
- UDI/DI 10885862086716
- Serial Numbers: 0982890
- 0982906
- 0982900
- 0982901
- 1034066
- 1034062
- 1034064
- 1034082
- 1034089
- 1034067
- 1034068
- 1034078
- 1034097
- 1071503
- 1071501
- 1034079
- 1071494
- 0982898
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 24 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 24 products in this recall →Related recalls
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