Exactech Equinoxe Shoulder Components Recalled for Nonconforming Packaging
Exactech is recalling 3,436 units of shoulder arthroplasty components due to nonconforming packaging that lacks a required oxygen barrier layer. The products may not be adequately protected against oxidative 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: FDA Class II recall for packaging specification non-conformance with no reported adverse events or injuries. The defect is precautionary in nature, comparable to minor labeling errors and packaging defects without reported patient harm.
Plain-English summary
Exactech, Inc. is recalling 3,436 units of Equinoxe CAGE GLENOID posterior augment cemented shoulder arthroplasty components (Item Numbers 314-13-22, 314-13-23, 314-13-24, and 314-13-25) distributed nationwide and internationally.
The recalled products were packaged in vacuum bags that do not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH), as required by the established packaging specification. This nonconforming packaging may not provide adequate protection against oxidative degradation of the UHMWPE (ultra-high molecular weight polyethylene) material in the humeral liners and glenoids.
No adverse events or patient injuries have been reported to date. The recall is precautionary to address the packaging specification non-conformance.
Healthcare providers and patients with affected implants should contact Exactech, Inc. to determine if their products are among those recalled and to discuss appropriate next steps. Affected products should not be used until the packaging issue is resolved.
The recalled product
- Product
- Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head…
- Manufacturer
- Exactech, Inc.
- Affected units
- 3,436
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 314-13-22
- UDI/DI 10885862196163
- Serial Numbers: 3864575
- 4108594
- 3864576
- 3926687
- 4172892
- 4155858
- 4122466
- 4172896
- 4108598
- 4108597
- 4122508
- 4257141
- 4122477
- 3864571
- 3926691
- 4122529
- 3864569
- 4268100
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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Similar recalls
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