FDAFDA · Food and drugs·Recall number Z-0582-2014
Stryker Orthopaedics Rim Impactor Tip Product Usage: Used for MDM surgery.
Published January 1, 2014 · Recall initiated: September 30, 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 has received complaints associated with cracks and/or fracture of the Ball Impactor Tip and Rim Impactor Tip Instruments.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Distributor
- USA Nationwide Distribution
- Lot
- Catalog number 12350-013 all lot codes
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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