FDA Enforcement
Class II
Terminated
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.
Recall: Z-1978-2014
·
Reported July 9, 2014
Enforcement
- Recall Number
- Z-1978-2014
- Event ID
- 68500
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Stryker Howmedica Osteonics Corp.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 9, 2014
- Initiation Date
- May 1, 2014
- Classification Date
- July 2, 2014
- Termination Date
- June 9, 2017
- Address
- 325 Corporate Dr, Mahwah, NJ, 07430-2002, United States
Description
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.
Reason
Tritanium Patella Inserter Instrument fracture during implantation. .
Code Info
Catalog No. 6541-3-530. Lot Codes: CTD2778 and CTD2779.
Distribution
US Nationwide Distribution - in the states of Arizona, Florida, Kentucky, Louisiana and New Jersey.
Quantity
22 Units