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

Recall Z-1124-2013 — REF 32-422760 Oxford Uni Knee System,Toffee Hammer, non-sterile, found in REF 32-422763 Oxford Mlcroplasty Knee System Tibial instrument Tray small surgical hammer supplied with the Oxford Partial Knee Microplasty Instrument set, used for impacting implants.

U.S. FDA — Device Enforcement · United Kingdom · 2013-03-20 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1124-2013
Date of alert: 2013-03-20
Country / jurisdiction: United Kingdom
Risk level: Class II
Risk type: recall
Brand: Biomet U.K., Ltd.
Product category: device
Product type: Devices

Reported risk: Investigation of complaints found excessive use of the instrument could result in cracking on the weld between the head and the handle, which could lead to part of the head becoming detached from the handle.

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

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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-1124-2013 — REF 32-422760 Oxford Uni Knee System,Toffee Hammer, non-sterile, found in REF 32-422763 Oxford Mlcroplasty Knee System Tibial instrument Tray small surgical hammer supplied with the Oxford Partial Knee Microplasty Instrument set, used for impacting implants.

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