Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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 Recall Z-1978-2014 · Posted 2014-07-02

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeLXH
Date Initiated2014-05-01
Date Terminated2017-06-09
Product Quantity22 Units

Reason for Recall

Tritanium Patella Inserter Instrument fracture during implantation. .

Firm 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).

Root Cause

Process control

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑