—#128089

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.

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Catalog No. 6541-3-530. Lot Codes: CTD2778 and CTD2779.

Why it was recalled

Tritanium Patella Inserter Instrument fracture during implantation. .

Root cause (FDA determination)

Process control

Action the firm took

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).

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2002

Distribution

Distribution pattern: US Nationwide Distribution - in the states of Arizona, Florida, Kentucky, Louisiana and New Jersey.

Timeline

Recall initiated: 2014-05-01
Posted by FDA: 2014-07-02
Terminated: 2017-06-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #128089. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.