Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0791-2013 — 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.

U.S. FDA — Device Enforcement · United States · 2012-12-17 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0791-2013
Date of alert: 2012-12-17
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Medacta Usa Inc
Product category: device
Product type: Devices

Reported risk: The tip of the Quadra Trial Broach size 0, broke during a surgery.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-0791-2013 — 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.

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