Exactech Equinoxe Shoulder Arthroplasty Liner Recalled for Nonconforming Packaging
Exactech recalls 447 units of Equinoxe Constrained Humeral Liner due to nonconforming packaging lacking required oxygen barrier layer (EVOH). Affected units were distributed nationwide and internationally.
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, injuries, or adverse events. The defect is a packaging specification nonconformance without documented patient harm, consistent with voluntary precautionary recalls.
Plain-English summary
Exactech, Inc. has recalled 447 units of the Equinoxe Constrained Humeral Liner (Item Numbers 320-40-10 and 320-40-13), a component used in shoulder arthroplasty procedures. The packaging is nonconforming—the vacuum bags do not contain an additional oxygen barrier layer made of Ethylene Vinyl Alcohol (EVOH), as required by established packaging specifications.
The affected products were distributed nationwide and internationally across multiple countries including Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, and Thailand. Specific serial numbers for the affected units have been identified.
The recalled product
- Product
- Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13, Shoulder Arthroplasty
- Manufacturer
- Exactech, Inc.
- Affected units
- 447
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) 320-40-10
- UDI/DI 10885862535054
- Serial Numbers: 5937242
- 5910691
- 5937233
- 5936848
- 6062040
- 5936849
- 6197662
- 6197672
- 6197682
- 6197680
- 6197683
- 6197674
- 6413423
- 6062107
- 6200990
- 6046848
- 6197006
- 6062047
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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