ClearanceBrief
Recall Z-1619-2012 ยท LXH Orthopedic Manual Surgical Instrument

Stryker Howmedica Osteonics Corp.

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 pr

DateMay 17, 2012 (initiated Oct 10, 2011)
StatusTerminated
ReasonStryker received a Product Experience Report (PER) that a swivel block was improperly oriented on a Triathlon Tibial Alignment Handle, catalog no. 6541-2-807.
Root causeDevice Design
ActionStryker 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.
Quantity6,126 Units
DistributionWorldwide Distribution - USA (nationwide) and the countries of Asia Pacific, Canada, Europe, Middle East and Africa (EMEA), and Japan
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.