Exactech Equinoxe Modular Reverse Pilot-Tip Reamer Recall for Labeling Clarification
Exactech is recalling Equinoxe Modular Reverse Pilot-Tip 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 classified as FDA Class II and involves a documentation update to clarify technique and prevent instrument breakage, fitting the criteria for moderate severity without reported injuries.
Plain-English summary
Exactech, Inc. is recalling the EXACTECH Equinoxe Modular Reverse Pilot-Tip Reamer, including catalog numbers 321-25-38, 321-25-42, and 321-25-46. The recall involves 2,069 units distributed across 31 U.S. states, Puerto Rico, and 21 international countries.
The recall is 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.
No specific illnesses or injuries are reported in the source text. The hazard is associated with potential instrument breakage due to improper technique not previously clarified in the documentation.
The recalled product
- Product
- EXACTECH Equinoxe Modular Reverse Pilot-Tip Reamer, Catalog #: 321-25-38, Catalog #: 321-25-42 and Catalog #: 321-25-46
- Manufacturer
- Exactech, Inc.
- Affected units
- 2,069
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.
See all 6 products in this recall →Related recalls
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