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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Orthopaedics Triathlon Tritanium Patella Inserter

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 Class 2 Device Recall Stryker Orthopaedics Triathlon Tritanium Patella Insertersee related information
Date Initiated by FirmMay 01, 2014
Date PostedJuly 02, 2014
Recall Status1 Terminated 3 on June 09, 2017
Recall NumberZ-1978-2014
Recall Event ID 68500
Product Classification Orthopedic manual surgical instrument - Product Code LXH
ProductStryker 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.
FEI Number 3003070421
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
For Additional Information ContactMr. Matthew Kelleher
201-972-2100
Manufacturer Reason
for Recall		Tritanium Patella Inserter Instrument fracture during implantation. .
FDA Determined
Cause 2		Process control
ActionStryker 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 Commerce22 Units
DistributionUS Nationwide Distribution - in the states of Arizona, Florida, Kentucky, Louisiana and New Jersey.
Total Product Life CycleTPLC 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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