Exactech Equinoxe Humeral Stem Recalled for Incorrect Instructions
Exactech is recalling 14 Equinoxe Humeral Stem devices because packages may include incorrect Instructions For Use (IFU).
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: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a documentation error (incorrect IFU) rather than a direct physical defect causing injury.
Plain-English summary
Exactech, Inc. is recalling 14 units of the Equinoxe Humeral Stem, Primary, Press Fit, 11mm. The recall is due to the potential for incorrect Instructions For Use (IFU) being included with the product packages.
The affected devices were distributed within the United States to Kansas, Ohio, and California, as well as internationally to Australia and Germany. The specific catalog number is 300-01-11, and the packaging lot is 49088921. The recall includes specific serial numbers ranging from 6477393 to 6477407.
Healthcare providers and patients should verify the serial numbers of their devices against the list provided by the manufacturer. If a device is affected, they should contact Exactech, Inc. for further instructions regarding the replacement or removal of the device.
The recalled product
- Product
- Equinoxe Humeral Stem, Primary, Press Fit, 11mm
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 14
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 (17)
- Catalog Number: 300-01-11
- Packaging Lot: 49088921
- UDI: 10885862079312
- Serial Numbers: 6477393
- 6477394
- 6477395
- 6477397
- 6477398
- 6477399
- 6477400
- 6477401
- 6477402
- 6477403
- 6477404
- 6477405
- 6477406
- and 6477407.
Distribution
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