Exactech Equinoxe Reamer Recalled for Updated Instructions on Glenoid Reaming
Exactech is recalling the Equinoxe Narrow Modular Reverse Pilot-Tip Starter Reamer to update instructions for use, clarifying proper reaming technique to prevent instrument breakage.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (surgical instrument breakage) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Exactech, Inc. is recalling the EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Starter Reamer (Catalog #: 321-45-01). The recall involves all lots of the product. The distribution pattern includes numerous U.S. states and territories, as well as multiple international countries including Australia, Canada, and the United Kingdom.
The recall is initiated to update the Instructions for Use (IFU) to clarify the proper technique and instrumentation for reaming the Glenoid. The updated instructions include a caution statement advising surgeons to ream on-axis, noting that reaming off-axis may result in instrument breakage.
This recall is classified as Class II by the FDA. The primary hazard identified is the potential for instrument breakage if the device is used off-axis. No specific illnesses or injuries are reported in the source text, but the risk of harm is associated with the failure of the surgical instrument during use.
The recalled product
- Product
- EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Starter Reamer Catalog #: 321-45-01
- Manufacturer
- Exactech, Inc.
- Hazard
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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