Medacta Quadra Trial Broach size 0 part # 01 — Class II medical device recall Z-0791-2013
Terminated recall by Medacta Usa Inc, reported 2013-02-13, distributed nationwide. The tip of the Quadra Trial Broach size 0, broke during a surgery.
| Recall number | Z-0791-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medacta Usa Inc, Camarillo, CA, United States |
| Recall initiated | 2012-12-17 |
| Classified | 2013-02-06 |
| Reported by FDA | 2013-02-13 |
| Terminated | 2013-02-07 |
| Distributed | Nationwide (US) |
| Model numbers | 045 |
Product
Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System. Product Usage - used to broach the intramedullary canal of the femur in order to create space for the femoral stem during a hip replacement surgery.
Reason for recall
The tip of the Quadra Trial Broach size 0, broke during a surgery.
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-0791-2013. 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.