FDA Device recall Z-0535-2026
Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product De…
- FDA Device
- Class II
- ongoing
- Published 2025-11-26
On 2025-11-26 the FDA classified a Class II recall of Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product De… by Exactech, citing due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0535-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-05 |
| Published | 2025-11-26 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Exactech |
| Distribution | SC |
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
Reason
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
Identifiers
| code_info | Lot Code: Part Number: 321-59-42, UDI-DI: 10885862593009, Lot Number: 410398-013 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Exactech
- Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05
FDA Device · Class II · 2026-03-18 · Exactech - Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X
FDA Device · Class II · 2026-03-18 · Exactech - Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Des…
FDA Device · Class II · 2025-11-26 · Exactech - Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product De…
FDA Device · Class II · 2025-11-26 · Exactech - Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38MM HUM LINER +2.5/…
FDA Device · Class II · 2025-09-24 · Exactech
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0535-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.