Exactech Equinoxe Modular Reverse Pilot-Tip Starter Reamer Recall
Exactech is recalling 928 Equinoxe Modular Reverse Pilot-Tip Starter Reamers to update instructions for use. The update clarifies proper reaming technique to prevent 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, but the source text indicates the issue is a documentation update to clarify technique and prevent instrument breakage, with no reported injuries or illnesses. This aligns with the 'Moderate' criteria for voluntary precautionary recalls or minor labeling/documentation issues where the risk is theoretical or manageable.
Plain-English summary
Exactech, Inc. is recalling 928 units of the EXACTECH Equinoxe Modular Reverse Pilot-Tip Starter Reamer (Catalog #: 321-25-01). The recall involves all lots of this medical device. The distribution pattern includes 31 U.S. states, Hawaii, and Puerto Rico, as well as 20 international countries including Australia, Canada, China, and the United Kingdom.
The recall is initiated to update the Instructions for Use (IFU). The updated documentation clarifies the proper technique and instrumentation required to ream the Glenoid. Specifically, the IFU now includes a caution statement advising surgeons to ream on-axis, noting that reaming off-axis may result in instrument breakage.
This recall is a Class II recall, indicating that use of or exposure to the violation may cause temporary or medically reversible adverse health consequences. No illnesses or injuries are reported in the source text. The primary hazard is the potential for instrument breakage during surgical procedures if the device is used off-axis.
The recalled product
- Product
- EXACTECH Equinoxe Modular Reverse Pilot-Tip Starter Reamer - Catalog #: 321-25-01
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 928
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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