Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) referencing instrument (Cat. No.
FDA device recall Z-2130-2013 · posted 2013-08-29 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Cracks or fracture of the Triathlon Tibial Alignment Ankle Clamp, an instrument.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GDJ
- Quantity affected
- 10,537 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2013-07-02
- Date posted
- 2013-08-29
- Date terminated
- 2016-04-27
- Location
- Mahwah, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.