FDAFDA · Food and drugs·Recall number Z-1978-2014
Stryker Orthopaedics Triathlon Tritanium Patella Inserter, . NON-STERILE Product Usage: The Triathlon Tritanium Patella Inserter is part of the Tritanium Knee System Instrument Set. It is used to implant the Tritanium Patella after the patellar bone has been prepared using the existing Triathlon Patella Resection Guide, Metal Backed Patella Drill and Patella Peg Drill Templates as per the Triathlon Tritanium Surgical Protocol.
Published July 9, 2014 · Recall initiated: May 1, 2014
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
Tritanium Patella Inserter Instrument fracture during implantation. .
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Distributor
- US Nationwide Distribution - in the states of Arizona, Florida, Kentucky, Louisiana and New Jersey.
- Lot
- Catalog No. 6541-3-530. Lot Codes: CTD2778 and CTD2779.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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