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

Recall Z-0964-2014 — Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single unit to a package Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France Made in USA non-sterile

U.S. FDA — Device Enforcement · United States · 2013-11-20 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0964-2014
Date of alert
2013-11-20
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 received reports from the field of the impaction plate dissociating/fracturing from the main body of the broach handle.
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.