Exactech Equinoxe Reverse Shoulder Humeral Liners Recalled for Nonconforming Packaging
Exactech, Inc. is recalling 24,303 units of Equinoxe Reverse Shoulder humeral liners due to nonconforming vacuum-bag packaging. The bags lack the required oxygen barrier layer, failing to meet packaging specifications.
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 recall with no reported illnesses or injuries. The hazard is a packaging specification defect with no documented clinical consequences. This represents a precautionary recall for non-conforming packaging.
Plain-English summary
Exactech, Inc. is recalling 24,303 units of the Exactech Equinoxe Reverse Shoulder 42mm humeral liners, including models 320-42-00 and 320-42-03, used in shoulder arthroplasty procedures.
The recalled units have nonconforming packaging. The vacuum bags do not contain the required additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH), as specified in the established packaging specification.
The affected devices were distributed nationwide in the United States and internationally to Canada, Australia, Austria, Belgium, Brazil, Chile, 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. The recall notice Z-1422-2024 identifies specific serial numbers of affected units.
The recalled product
- Product
- Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
- Manufacturer
- Exactech, Inc.
- Hazard
- non-conforming-packaging
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 320-42-00
- UDI/DI 10885862086693
- Serial Numbers: 0982062
- 1064609
- 1093925
- 1000132
- 1000124
- 1064624
- 1000137
- 1064629
- 1064643
- 1064639
- 1093902
- 1064617
- 1093913
- 1093909
- 1093905
- 1000121
- 1000115
- 1064610
Distribution
Distributed nationwide across the United States.
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