Stryker Howmedica Osteonics Corp. Triathlon Revision Instruments; 1,2,7,8 TGC Upper Tray; Non Sterile, Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430. For total knee arthroplasty procedures involving Triathlon Total Stabilizer components. The trays sterilize and transport instruments needed for such procedures. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Triathlon Revision Instruments; 1,2,7,8 TGC Upper Tray; Non Sterile, Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430. For total knee arthroplasty procedures involving Triathlon Total Stabilizer components. The trays sterilize and transport instruments needed for such procedures.
Brand
Stryker Howmedica Osteonics Corp.
Lot Codes / Batch Numbers
Catalog Numbers: 6543-8-014, 6543-8-015.
Products Sold
Catalog Numbers: 6543-8-014, 6543-8-015.
Stryker Howmedica Osteonics Corp. is recalling Triathlon Revision Instruments; 1,2,7,8 TGC Upper Tray; Non Sterile, Howmedica Osteonics Corp., 325 due to The screen print for the Valgus Adapter catalog numbers on the Triathlon Trial Cutting Guide Instrument Trays is incorrect.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The screen print for the Valgus Adapter catalog numbers on the Triathlon Trial Cutting Guide Instrument Trays is incorrect.
Recommended Action
Per FDA guidance
Stryker Orthopaedics issued an "Urgent Product Correction" notice dated May 15, 2009 via Federal Express addressed to Branch/Agency Manager/Quality Contact informing them of the affected device. The letter outlined instructions for correction and requested consignees to complete and return a Product Correction Acknowledgment Form by fax to 1-201-831-6069. Questions can be directed to Colleen O'Meara, Manager, Divisional Regulatory Reporting at 201-831-5970.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026