FDA Medical Device Recalls (openFDA)
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 number
- Z-0760-2010
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- 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.
- Status
- Terminated
- Initiated
- 2009-12-10
- Posted
- 2010-02-01
- Terminated
- 2012-08-28
- Reason
- Triathlon TS femoral components may have been damaged during manufacturing, possibly preventing the assembly of a stem extension.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 10
- Distribution
- Worldwide Distribution -- United States (DE, NC, OH. MI, TX, CA, MA, NJ, TN, KS, GA, FL, AL, IN, MN, MD, NE, AR, OK, CO, AZ, OR, and MA), Australia, United Kingdom and Canada.
- Lot, serial or model codes
- Catalog number: 5512-F-501; Lot codes: XAVN, XAVP and XBAL.
- 510(k) numbers
- ["K070095"]
- PMA numbers
- not on file
- Product code
- JWH
- Firm FEI
- 3003070421
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28