Stryker Howmedica Osteonics Corp. Triathlon Total Stabilizer Femoral Component; For Use with TS Components; Sterile, Made in the USA Stryker Orthopaedics, Mahwah, NJ 07430. The Triathlon Total Knee System components are intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Triathlon Total Stabilizer Femoral Component; For Use with TS Components; Sterile, Made in the USA Stryker Orthopaedics, Mahwah, NJ 07430. The Triathlon Total Knee System components are intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function.
Brand
Stryker Howmedica Osteonics Corp.
Lot Codes / Batch Numbers
Catalog number: 5512-F-301, Lot coded: XKYG, XKYH, YBTHR1 and YEUAR1.
Products Sold
Catalog number: 5512-F-301; Lot coded: XKYG, XKYH, YBTHR1 and YEUAR1.
Stryker Howmedica Osteonics Corp. is recalling Triathlon Total Stabilizer Femoral Component; For Use with TS Components; Sterile, Made in the USA S due to Triathlon TS femoral components may have been damaged during manufacturing, possibly preventing the assembly of a stem extension.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Triathlon TS femoral components may have been damaged during manufacturing, possibly preventing the assembly of a stem extension.
Recommended Action
Per FDA guidance
An "Urgent Product Recall" Letter dated December 10, 2009 was sent by Federal Express to all Stryker Branches, Chief of Orthopaedics, Hospital Risk Management and Surgeons. The letter described the affected product, issue and potential hazards. Consignees were instructed to complete Product Recall Acknowledgement Form and return to Stryker Orthopaedics via fax at 1-201-831-6069. All questions regarding the recall should be directed to Stryker Orthopaedics at 1-201-972-2100.
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