FDAFDA · Food and drugs·Recall number 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
Published February 19, 2014 · Recall initiated: November 20, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Stryker received reports from the field of the impaction plate dissociating/fracturing from the main body of the broach handle.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Distributor
- IL MA, MN, ND, OR, & PA
- Lot
- Catalog no. 2124-1400 All lots
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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