Stryker Orthopaedics Triathlon Tritanium Patella Inserter, . NON-STERILE Product Usage: The Triathlon Tritanium Patella
FDA device recall Z-1978-2014 · posted 2014-07-02 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Tritanium Patella Inserter Instrument fracture during implantation. .
- Action taken
- 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
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 22 Units
- Distribution
- US Nationwide Distribution - in the states of Arizona, Florida, Kentucky, Louisiana and New Jersey.
- Date initiated
- 2014-05-01
- Date posted
- 2014-07-02
- Date terminated
- 2017-06-09
- Location
- Mahwah, NJ
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