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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock

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  Class 2 Device Recall Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock see related information
Date Initiated by Firm June 23, 2016
Create Date August 11, 2016
Recall Status1 Open3, Classified
Recall Number Z-2390-2016
Recall Event ID 74619
510(K)Number K123486  
Product Classification Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/ - Product Code MBH
Product Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock, Non-Sterile,
Used to complement or replace the standard instruments used during the implantation of hip, knee, trauma and upper extremities implants
Code Information Catalog No: I-K3254TA00, Lot Nos: F6E13243, F6L13864, F6M14078, F6S14667, F6S14831, F6W15444, F6W15406, F7C15943, F7H16099 and F7L16994
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
For Additional Information Contact Mr. Michael Van Ryn
201-831-5000
Manufacturer Reason
for Recall
It was reported that the secondary locking mechanism, and its corresponding components, disassociated from the Specialty Triathlon Tibial Alignment Handle with Secondary Lock Assembly during surgery. Upon further investigation, it was discovered that the weld, which was intended to hold the secondary locking mechanism together, did not meet the weld size specified on the engineering drawing.
FDA Determined
Cause 2
Process control
Action Stryker sent an Urgent Product Recall letter dated June 24, 2016, with a Business Reply Form attached to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to inform users of the Urgent Product Recall letter and forward the notice to all those individuals who need to be aware within their organization. Customers were instructed to return all affected product at their location to: Stryker C/O Stericycle 2670 Executive Dr., Suite A Indianapolis, IN 46241 Customers were also instructed to complete and sign the enclosed Business Reply Form and fax it to 888-912-7352 or email to Stericycle at strykerortho4582@stericycle.com. Customers with questions were advised to call (201) 831-6693. For questions regarding this recall call 201-831-5000.
Quantity in Commerce 47 units
Distribution Nationwide Distribution to FL, IN, LA, NC, PA, TN and UT
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MBH and Original Applicant = Stryker
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