Device product
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.
Z-1978-2014
Product summary
- Event
- Event 68500
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22 Units
- Official record key
device-enforcement:Z-1978-2014
Official wording
Reason: Tritanium Patella Inserter Instrument fracture during implantation. .
Code information: Catalog No. 6541-3-530. Lot Codes: CTD2778 and CTD2779.
Distribution pattern: US Nationwide Distribution - in the states of Arizona, Florida, Kentucky, Louisiana and New Jersey.
Derived failure modes
-
Unknown
Tritanium Patella Inserter Instrument fracture during implantation. .