Drug recall
Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single unit to a package Howmedica…
FDA recall event 67234 · Class II · Stryker Howmedica Osteonics Corp.
Key facts
| Event ID | 67234 |
|---|---|
| Recall numbers | Z-0964-2014 |
| Recalling firm | Stryker Howmedica Osteonics Corp. |
| Product type | Devices |
| Products | Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single unit to a package Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Stryker France ZAC Satolas Green… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Stryker received reports from the field of the impaction plate dissociating/fracturing from the main body of the broach handle. |
| Initiation date | Nov 20, 2013 |
| Report date | Feb 19, 2014 |
| Termination date | Oct 13, 2016 |
| 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: