Quadra S Offset Broach Handle The offset broach handle is intended to… — Class II medical device recall Z-0267-2013
Terminated recall by Medacta Usa Inc, reported 2012-11-14, distributed in CO, NV, TX. Medacta USA Inc has initiated a recall on the Quadra S Offset Broach Handle because of the potential of the ri
| Recall number | Z-0267-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medacta Usa Inc, Camarillo, CA, United States |
| Recall initiated | 2008-10-13 |
| Classified | 2012-11-08 |
| Reported by FDA | 2012-11-14 |
| Terminated | 2012-11-09 |
| Distributed | CO, NV, TX |
| Countries outside the US | BE |
| Quantity | 12 units |
| Lot numbers | 085119, 085120, 085243, 085244 |
| Model numbers | 122, 123, 124, 125 |
Product
Quadra S Offset Broach Handle The offset broach handle is intended to attach to the broaches of different sizes as the surgeon broaches the femoral bone in preparation for the implantation of the femoral stem.
Reason for recall
Medacta USA Inc has initiated a recall on the Quadra S Offset Broach Handle because of the potential of the rivet that locks the metallic wire to the lever may become loose during a surgery and make it impossible to lock/unlock the broaches.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0267-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.