Recall Z-1978-2014 ยท LXH Orthopedic Manual Surgical Instrument
Stryker Howmedica Osteonics Corp.
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 Triathl
| Date | Jul 2, 2014 (initiated May 1, 2014) |
| Status | Terminated |
| Reason | Tritanium Patella Inserter Instrument fracture during implantation. . |
| Root cause | 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 | 22 Units |
| Distribution | US Nationwide Distribution - in the states of Arizona, Florida, Kentucky, Louisiana and New Jersey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.