Drug recall
Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Left and Right A//P Sizer Adjustment…
FDA recall event 64456 · Class II · Stryker Howmedica Osteonics Corp.
Key facts
| Event ID | 64456 |
|---|---|
| Recall numbers | Z-0964-2013 |
| Recalling firm | Stryker Howmedica Osteonics Corp. |
| Product type | Devices |
| Products | Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Left and Right A//P Sizer Adjustment Housing PER File K2401. For use in knee prosthesis implantation. NON-STERILE |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The standard Triathlon Femoral Stylus does not fit into the Specialty Sizers and the "R" and "L" markings on the Right Sizer are reversed. |
| Initiation date | Jan 24, 2013 |
| Report date | Mar 27, 2013 |
| Termination date | May 6, 2015 |
| City | Mahwah |
| State | NJ |
| Country | United States |
| FEI number | 3003070421 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: