Exactech Equinoxe Cage Glenoid Posterior Augment Recalled for Mislabeling
Exactech, Inc. is recalling 69 Equinoxe Cage Glenoid, Posterior Augment, Left, Medium devices because they may be mislabeled.
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 the source text identifies the hazard as potential mislabeling without reporting of injuries or illnesses, fitting the criteria for a moderate severity rating.
Plain-English summary
Exactech, Inc. is recalling 69 units of the Equinoxe Cage Glenoid, Posterior Augment, Left, Medium (Catalog 314-13-23). The recall was initiated because the product may be mislabeled.
The affected devices were distributed to consignees in the United States and internationally. US distribution included 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.
Consumers and healthcare providers should check their inventory for the specific serial numbers listed in the recall notice. If the product is found, it should be removed from use and returned to the manufacturer or the appropriate regulatory authority as directed.
The recalled product
- Product
- Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 69
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 314-13-23
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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