||May 17, 2012
||Terminated on September 10, 2014
|Recall Event ID
Orthopedic Manual Surgical Instrument - Product Code LXH
||Tibial Alignment Handle
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.
||Catalog No.: 6541-2-807
customer Parts associated with cat. no. 6540-2-807
I-K2072AH00 - Triathlon Tibial Align. Handle with Secondary Lock
I-K2336AH00 - Tibial Alignment Handle with Lock
I-K2021TA00 - Triathlon Alignment Handle with Navigation Post
I-K2059KT00 - Triathlon Tibia Alignment Handle
I-K3254TA00 - Triathlon Tibial Alignment Handle with Lock
I-K3251AH00 - Triathlon Tibial Alignment Handle for Sizes 1-3
I-K3113TH00 - Triathlon Tibial Alignment Handles (Augment)
I-K2980 - Triathlon Tibia Alignment Handle
I-K2954AH00 - Triathlon Tibia Alignment Handle
I-K2916TA00 - Triathlon Tibial Alignment Handle
I-K2797AH00 - Tibial Alignment Handle with no swivel
Catalog No. 6541-2-8089
|Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, New Jersey 07430
|For Additional Information Contact
||Ms. Colleen O'Meara
|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.
|DESIGN: Device Design
||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.
|Quantity in Commerce
||Worldwide Distribution - USA (nationwide) and the countries of Asia Pacific, Canada, Europe, Middle East and Africa (EMEA), and Japan
|Total Product Life Cycle
TPLC Device Report
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.