Shoulder Implant Components Recalled for Nonconforming Packaging
Exactech Inc. is recalling 11,031 shoulder implant components due to nonconforming vacuum bag packaging lacking a required oxygen barrier layer. The missing Ethylene Vinyl Alcohol (EVOH) layer could allow oxygen exposure to the UHMWPE material.
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: FDA Class II recall with no reported illnesses or injuries. The defect is nonconforming packaging that could theoretically compromise implant material integrity but represents a preventive/precautionary recall rather than a demonstrated safety hazard.
Plain-English summary
Exactech, Inc. is recalling 11,031 units of Equinoxe shoulder implant components (CAGE GLENOID cemented glenoid and UHMWPE humeral liners) used in shoulder replacement surgery. The recalled units have nonconforming packaging—the vacuum bags lack a required Ethylene Vinyl Alcohol (EVOH) oxygen barrier layer specified in the product design.
The missing oxygen barrier layer could allow ambient oxygen to reach the ultra-high-molecular-weight polyethylene (UHMWPE) material during storage, potentially compromising material integrity. This is a storage and packaging issue, not a defect in the devices themselves.
The affected units were distributed nationwide and internationally to Australia, Austria, Belgium, Brazil, Chile, Canada, China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, and Thailand. Hospitals and surgical centers should verify inventory against the provided serial numbers and discontinue use of affected units. Patients implanted with these components should contact their surgeon if they have concerns.
The recalled product
- Product
- Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
- Manufacturer
- Exactech, Inc.
- Affected units
- 11,031
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 314-13-02
- UDI/DI 10885862172679
- Serial Numbers: 2334190
- 2334196
- 2334178
- 2334192
- 2334193
- 2330945
- 2177477
- 2177488
- 2330864
- 2330867
- 2177487
- 2330948
- 2339049
- 2452141
- 2334179
- 2334191
- 2177486
- 2334180
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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