FDA Medical devices recall ·
Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model recall
- Recall number
- Z-0535-2026
- Date
- (initiated September 5, 2025)
- Company / brand
- Exactech, Inc.
2320 Nw 66th Ct, Gainesville, FL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Code: Part Number: 321-59-42, UDI-DI: 10885862593009, Lot Number: 410398-013
Distribution
U.S.: SC O.U.S.: N/A
States: South Carolina
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0535-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.