Shoulder reamers recalled after release without completed performance testing
Exactech is recalling one Equinoxe Ergo Adjustable Angle rTSA Reamer, 42mm, because it was released before design updates and performance testing were completed.
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: Scored 2 because the record cites release before testing was completed rather than a confirmed defect or reported harm.
Plain-English summary
The Exactech Equinoxe Ergo Adjustable Angle rTSA Reamer, 42mm, catalog number 321-59-42, is being recalled.
The recall follows products that have not completed design updates and performance testing being released and distributed. The firm states the products may not conform to design and performance criteria.
The recall covers 1 unit carrying UDI-DI 10885862593009, from lot 410398-013, distributed in South Carolina. The FDA has classified the action as Class II.
The enforcement record cites the incomplete testing without describing a confirmed nonconformance or health consequence, and reports no injuries. Facilities holding the affected lot should follow Exactech's instructions.
The recalled product
- Product
- Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product Description: rTSA Reamer, 42mm Component: Not a component
- Manufacturer
- Exactech, Inc.
- Affected units
- 1
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 (3)
- Lot Code: Part Number: 321-59-42
- UDI-DI: 10885862593009
- Lot Number: 410398-013
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 3 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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