Tibial Alignment Handle Triathlon Instruments CAT #: 6541-2-807 Nav Tibial Alignment Handle Triathlon Instruments CAT #; 6541-2-808 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 The tibial alignment handles Cat# 6451-2-807 and 6541-2-808 are part of the Triathlon Knee Instruments set. The alignment handle is used after the tibial resection portion of a total knee arthroplasty procedure. The alignment handle helps holding and orienting the tibial template and trial, which are used to estimate the size and assess the orientation of the final implant. The implant will provide the new bearing surface of the knee, replacing the damaged joint.
FDA Recall Z-1619-2012 · Posted 2012-05-17
Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeLXH
Date Initiated2011-10-10
Date Terminated2014-09-10
Product Quantity6,126 Units
Reason for Recall
Stryker received a Product Experience Report (PER) that a swivel block was improperly oriented on a Triathlon Tibial Alignment Handle, catalog no. 6541-2-807.
Firm Action
Stryker sent an Urgent Product Field Action letter dated October 10, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact their Stryker Sales Representative to arrange for return of the affected product . Customers were asked to fax back the attached Poroduct Field Action Acknowledgement Form as soon as possible to 201-831-6069. For any questions customers were instructed to call 201-972-2100.
For questions regarding this recall call 201-831-3523.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution - USA (nationwide) and the countries of Asia Pacific, Canada, Europe, Middle East and Africa (EMEA), and Japan
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.