Exactech Equinoxe Reverse Starter Reamer Recalled for Updated Instructions
Exactech is recalling 382 Equinoxe Reverse Starter Reamers to update instructions for use, clarifying that off-axis reaming may cause instrument breakage.
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. The hazard is instrument breakage due to improper technique, which is a risk-of-harm scenario without reported injuries, fitting the Moderate category for precautionary updates to prevent potential issues.
Plain-English summary
Exactech, Inc. is recalling 382 units of the EXACTECH Equinoxe Reverse Starter Reamer (Catalog #: 321-05-01). The recall involves all lots of the product. 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 for reaming the Glenoid. Specifically, a caution statement is added to advise that the surgeon should ream on-axis, noting that reaming off-axis may result in instrument breakage.
This recall affects healthcare facilities and surgeons who have received or used this specific reamer. The source text does not provide specific instructions for consumers or end-users, as the product is a medical device intended for professional use. No illnesses or injuries are reported in the source text.
The recalled product
- Product
- EXACTECH Equinoxe Reverse Starter Reamer - Catalog #: 321-05-01
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 382
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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