Exactech Equinoxe Shoulder Implants Recalled for Nonconforming Packaging
Exactech is recalling 12,643 units of Equinoxe CAGE GLENOID shoulder implants because packaging lacks a required oxygen barrier layer. Units were vacuum-sealed without the proper Ethylene Vinyl Alcohol (EVOH) barrier.
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: This is an FDA Class II recall involving a packaging specification nonconformity without reported illnesses or injuries. The missing oxygen barrier is a precautionary issue to ensure proper storage conditions, consistent with low-risk contamination recalls.
Plain-English summary
Exactech, Inc. is recalling 12,643 units of Equinoxe CAGE GLENOID, CEMENTED shoulder implants used in shoulder arthroplasty procedures due to nonconforming packaging. The affected implants were packaged in vacuum bags that do not include the required additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).
The missing EVOH barrier layer does not meet established packaging specifications. Without this oxygen barrier, the UHMWPE (ultra-high molecular weight polyethylene) humeral liners and glenoids may be exposed to oxygen during storage and transport, which could affect device integrity and stability.
The recall affects units 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.
Healthcare providers should verify their inventory against the affected serial numbers provided by Exactech and cease use of affected units until replacements with compliant packaging can be obtained. Contact Exactech, Inc. for replacement units and additional information regarding this recall.
The recalled product
- Product
- Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
- Manufacturer
- Exactech, Inc.
- Affected units
- 12,643
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 314-13-13
- UDI/DI 10885862172693
- Serial Numbers: 2204820
- 2204812
- 2204813
- 2204815
- 2452178
- 2500820
- 2499638
- 2331072
- 2427399
- 2331064
- 2204830
- 2336229
- 2427393
- 2204831
- 2204818
- 2336244
- 2336253
- 2336241
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.
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