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

Recall Z-1816-2012 — Stryker Howmedica Osteonics Accolade Offset Rasp Handle Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France Single offset rasp handle designed to mate to the Accolade femoral broaches to prep

U.S. FDA — Device Enforcement · United States · 2011-12-29 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1816-2012
Date of alert: 2011-12-29
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Stryker Howmedica Osteonics Corp.
Product category: device
Product type: Devices

Reported risk: Stryker Orthopaedics has become aware of the potential for the above noted Accolade Rasp Handle Assembly to fracture upon use.

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.

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