Exactech Equinoxe Humeral Liner Shoulder Implant Recalled for Nonconforming Packaging
Exactech Equinoxe Humeral Liners used in shoulder surgery are being recalled due to nonconforming packaging. Approximately 2,806 units lack the required oxygen barrier layer in their vacuum-bag packaging.
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: This is an FDA Class II recall involving a packaging specification defect rather than a device design flaw. No injuries or illnesses have been reported. The missing oxygen barrier is a real non-conformance, but the source does not characterize the specific risk to patients.
Plain-English summary
Exactech Equinoxe Humeral Liners (Item Numbers 320-40-00 and 320-40-03) for shoulder replacement surgery are being recalled. Approximately 2,806 units were distributed nationwide and internationally to multiple countries including Australia, Austria, Belgium, Brazil, Canada, 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 packaging of the affected humeral liners does not meet the established packaging specification. Specifically, the units were packaged in vacuum bags that do not contain the required oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).
Healthcare providers and facilities with these products should consult the FDA recall notice (Z-1420-2024) for the complete list of affected serial numbers and further guidance from Exactech, Inc. regarding these devices.
The recalled product
- Product
- Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
- Manufacturer
- Exactech, Inc.
- Hazard
- packaging-defect
- oxygen-barrier-missing
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) 320-40-00
- UDI/DI 10885862535030
- Serial Numbers: 6173429
- 5867573
- 6007454
- 6007478
- 5927587
- 6008225
- 6007520
- 5927562
- 5927516
- 5927575
- 6197331
- 6196344
- 5867550
- 5927586
- 6196429
- 5876444
- 6196833
- 5867568
Distribution
Distributed nationwide across the United States.
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