Date Initiated by Firm |
May 01, 2014 |
Date Posted |
July 02, 2014 |
Recall Status1 |
Terminated 3 on June 09, 2017 |
Recall Number |
Z-1978-2014 |
Recall Event ID |
68500 |
Product Classification |
Orthopedic manual surgical instrument - Product Code LXH
|
Product |
Stryker Orthopaedics Triathlon Tritanium Patella Inserter, . NON-STERILE
Product Usage: The Triathlon Tritanium Patella Inserter is part of the Tritanium Knee System Instrument Set. It is used to implant the Tritanium Patella after the patellar bone has been prepared using the existing Triathlon Patella Resection Guide, Metal Backed Patella Drill and Patella Peg Drill Templates as per the Triathlon Tritanium Surgical Protocol. |
Code Information |
Catalog No. 6541-3-530. Lot Codes: CTD2778 and CTD2779. |
Recalling Firm/ Manufacturer |
Stryker Howmedica Osteonics Corp. 325 Corporate Dr Mahwah NJ 07430-2002
|
For Additional Information Contact |
Mr. Matthew Kelleher 201-972-2100
|
Manufacturer Reason for Recall |
Tritanium Patella Inserter Instrument fracture during implantation. .
|
FDA Determined Cause 2 |
Process control |
Action |
Stryker Orthopaedics issued an "Urgent Medical Device Recall Notification" letters/Notification Acknowledgement forms dated May 7, 2014 to their customers via Fed-Ex on May 7, 2014. The notification informs the customers of the issue(s) with the affected product; potential hazards; and how to identify and handle any affected product. Customers were instructed to return any affected product to Stryker Orthopaedics and fill out and return the enclosed Notification Acknowledgement form. For questions call (1-201-972-2100). |
Quantity in Commerce |
22 Units |
Distribution |
US Nationwide Distribution - in the states of Arizona, Florida, Kentucky, Louisiana and New Jersey. |
Total Product Life Cycle |
TPLC Device Report
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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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