Offset Adaptor Trial - 6MM, Triathlon Revision Instruments. Non-Sterile; Howmedica Osteonics Corp: 325 Corporate Drive, Mahwah, NJ 07430. Indications for use include disabling joint disease of the knee.
This recall has been terminated (originally issued July 23, 2009).
- Recall Initiated
- April 16, 2009
- Posted
- July 23, 2009
- Terminated
- April 5, 2010
- Recall Number
- Z-1609-2009
- Quantity
- 2498 units, all sizes
- Firm Location
- Mahwah, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Triathlon Offset Adaptors may seize during surgery and the OR staff may be unable to disassemble the instrument using the removal tool.
Distribution
Worldwide Distribution.
Lot / Code Info
Catalog Number 5570-T-060; All Lot Numbers.
Root Cause
Process control
Action Taken
"Urgent Product Correction" letters dated April 16, 2009 were sent to all Stryker Representatives, Hospital Rick Management Departments, Hospital Chief of Orthopaedics, Surgeon and countries by Federal Express. The notice explains the Issue, Potential Hazards and Risk Mitigation Factors of the affected product(s) including a request to complete and return the Product Correction Form. For further questions, contact Stryker Orthopedics, Division of Regulatory Reporting at 201-831-5970.