FDA Device recall Z-1978-2014
Stryker Orthopaedics Triathlon Tritanium Patella Inserter, . NON-STERILE Product Usage: The Triathlon Tritanium Patella Inserter is part of…
- FDA Device
- Class II
- terminated
- Published 2014-07-09
On 2014-07-09 the FDA classified a Class II recall of Stryker Orthopaedics Triathlon Tritanium Patella Inserter, . NON-STERILE Product Usage: The Triathlon Tritanium Patella Inserter is part of… by Stryker Howmedica Osteonics, citing tritanium Patella Inserter Instrument fracture during implantation. .
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1978-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-05-01 |
| Published | 2014-07-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stryker Howmedica Osteonics |
| Distribution | US |
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.
Reason
Tritanium Patella Inserter Instrument fracture during implantation. .
Identifiers
| code_info | Catalog No. 6541-3-530. Lot Codes: CTD2778 and CTD2779. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1978-2014%22
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