Stryker Orthopaedics Triathlon Tritanium Patella Inserter — Class II medical device recall Z-1978-2014
Terminated recall by Stryker Howmedica Osteonics Corp., reported 2014-07-09, distributed nationwide. Tritanium Patella Inserter Instrument fracture during implantation. .
| Recall number | Z-1978-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2014-05-01 |
| Classified | 2014-07-02 |
| Reported by FDA | 2014-07-09 |
| Terminated | 2017-06-09 |
| Distributed | Nationwide (US) |
| Quantity | 22 units |
| Reason classes | device malfunction |
| Lot numbers | CTD2778, CTD2779 |
| Model numbers | 6541-3-530 |
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 for recall
Tritanium Patella Inserter Instrument fracture during implantation. .
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1978-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.