Exactech Equinoxe Glenoid Reamer Recalled for Updated Instructions
Exactech is recalling Equinoxe Glenoid Reamers to update instructions for use, clarifying that off-axis reaming may cause instrument breakage.
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: The recall is a Class II recall involving a documentation update to clarify technique and prevent instrument breakage, which fits the criteria for moderate severity as a precautionary labeling/instruction correction without reported injuries.
Plain-English summary
Exactech, Inc. is recalling 813 units of the EXACTECH Equinoxe Glenoid Reamer (Catalog #s 321-05-38, 321-05-42, and 321-05-46). The recall involves all lots of the product.
The recall was initiated to update the Instructions for Use (IFU) to clarify the proper technique and instrumentation for reaming the Glenoid. The updated documentation includes a caution statement advising surgeons to ream on-axis, noting that reaming off-axis may result in instrument breakage.
The affected units were distributed to 31 U.S. states, Hawaii, and Puerto Rico, as well as 20 international countries including Australia, Canada, and the United Kingdom. Healthcare providers should review the updated instructions and ensure proper on-axis technique is used to prevent instrument breakage.
The recalled product
- Product
- EXACTECH Equinoxe Glenoid Reamer - Catalog #: 321-05-38, Catalog #: 321-05-42, and Catalog #: 321-05-46
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 813
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)
- All Lots
Distribution
Part of a larger recall action
This product is one of 6 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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