Exactech Equinoxe Shoulder Arthroplasty Components Recalled for Defective Packaging
Exactech recalls 39 UHMWPE shoulder arthroplasty components due to nonconforming vacuum packaging that lacks the required oxygen barrier layer.
What this means for you
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 precautionary recall due to packaging specification nonconformance with no reported illnesses or injuries. The missing oxygen barrier is a low-risk contamination concern but does not meet criteria for higher severity without evidence of actual harm.
Plain-English summary
Exactech, Inc. is recalling 39 units of UHMWPE components used in shoulder arthroplasty (shoulder replacement surgery), including glenoid and humeral liner parts. The recall is due to packaging nonconformance: the vacuum bags do not contain the required additional oxygen barrier layer made of Ethylene Vinyl Alcohol (EVOH).
The affected components are distributed nationwide in the United States and internationally across multiple countries. Specific item numbers and serial numbers for the affected products have been identified and are available through the FDA recall notice.
The FDA classified this as a Class II recall. No illnesses or injuries have been reported related to these products. Exactech initiated this recall in cooperation with the FDA.
Patients or healthcare providers in possession of affected units should contact Exactech for replacement components. The packaging specification requires an EVOH barrier layer to maintain proper product protection during storage and distribution.
The recalled product
- Product
- Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-04-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-04-33, c) 44, 47, 50, 53 head, Large, Item Number 314-04-34, d) 44,
- Manufacturer
- Exactech, Inc.
- Hazard
- packaging-defect
- oxygen-barrier-defect
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 314-04-32
- UDI/DI 10885862199553
- Serial Numbers: 2111957
- 2161636
- 2111956
- 2161639
- 3755661
- b) Item Number 314-04-33
- UDI/DI 10885862199560
- Serial Numbers: 2112015
- 2112016
- 2112013
- 2112014
- 2136760
- 2136755
- 2424239
- 2424237
- 2136756
- 2424241
- 2712715
Distribution
Distributed nationwide across the United States.
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