FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) referencing instrument (Cat. No. 6541-2-609), for use in Total Knee Arthroplasty (TKA) when the surgeon elects to use Stryker's Triathlon Total Knee System in conjunction with EM referencing. Non-Sterile Instrument.
- Recall number
- Z-2130-2013
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) referencing instrument (Cat. No. 6541-2-609), for use in Total Knee Arthroplasty (TKA) when the surgeon elects to use Stryker's Triathlon Total Knee System in conjunction with EM referencing. Non-Sterile Instrument.
- Status
- Terminated
- Initiated
- 2013-07-02
- Posted
- 2013-08-29
- Terminated
- 2016-04-27
- Reason
- Cracks or fracture of the Triathlon Tibial Alignment Ankle Clamp, an instrument.
- Root cause
- Device Design
- Action
- Stryker Orthopaedics sent an Urgent Medical Device Correction letter dated July 2, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by t he customers. Customers are advised of the issue, potential hazards and risk mitigation factors. Customers are asked to complete the attached form and fax to 855-251-3635. Any questions should be directed to (201) 972-2100. All letters included a Product Correction Bulletin.
- Quantity
- 10,537 units
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Catalog #6541-2-609 All lot codes
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GDJ
- 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