| Date Initiated by Firm |
October 10, 2011 |
| Date Posted |
May 17, 2012 |
| Recall Status1 |
Terminated 3 on September 10, 2014 |
| Recall Number |
Z-1619-2012 |
| Recall Event ID |
61343 |
| Product Classification |
Orthopedic manual surgical instrument - Product Code LXH
|
| Product |
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. |
| Code Information |
Catalog No.: 6541-2-807 N1A0l, N1K07 N1K14 N1N64 N1W04 N2A11 N2H10 N2L16 N2N04 N2V25 N2V26 N3E08 N3H12 N3H29 N3K02 N3K56 N3L13 N3S33 N3S39 N3T78 N3V21 N3W18 N3W29 N3W47 NYC02 NYC10 NYL09 NZC10 NZH09 NZL08 NZM01 NZS08 NZV09 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 N1K14 N1N63 N1W08 N3K50 N3M43 N3T61 N3V56 N4E36 |
Recalling Firm/
Manufacturer |
Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah NJ 07430
|
| For Additional Information Contact |
Ms. Colleen O'Meara
201-831-5523
|
Manufacturer 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.
|
FDA Determined
Cause 2 |
Device Design |
| 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. |
| Quantity in Commerce |
6,126 Units |
| Distribution |
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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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