Exactech Equinoxe Cage Glenoid Posterior Augment Recalled for Mislabeling
Exactech is recalling 40 Equinoxe Cage Glenoid, Posterior Augment, Right, Medium devices due to potential mislabeling. The devices were distributed to US and international consignees.
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 and involves a labeling error without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Exactech, Inc. is recalling 40 units of the Equinoxe Cage Glenoid, Posterior Augment, Right, Medium (Catalog 314-13-33). The recall is being conducted because the product may be mislabeled. The affected devices have specific serial numbers ranging from 6132993 to 6259595.
The recalled devices were distributed to consignees in the United States, including Arizona, California, Colorado, Florida, Illinois, Indiana, Kentucky, Louisiana, Maryland, Maine, Minnesota, Nevada, New York, Ohio, Oklahoma, South Carolina, Tennessee, Texas, Virginia, Washington, and Wisconsin. International distribution included Australia, Japan, and the United Kingdom.
Healthcare providers and patients should check their inventory and patient records for these specific serial numbers. If the device is found, it should be removed from use and returned to Exactech, Inc. according to their instructions. This recall is classified as Class II by the FDA.
The recalled product
- Product
- Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 40
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 (1)
- Catalog 314-13-33
Distribution
Part of a larger recall action
This product is one of 2 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.
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