Drug recall
Radio-Capitellum, Capitellum, Left, Large, Do Not Reuse, Rx Only. Indicated for use in the elbow for reduction…
FDA recall event 71676 · Class II · Stryker Howmedica Osteonics Corp.
Key facts
| Event ID | 71676 |
|---|---|
| Recall numbers | Z-2426-2015, Z-2427-2015, Z-2428-2015, Z-2429-2015, Z-2430-2015 |
| Recalling firm | Stryker Howmedica Osteonics Corp. |
| Product type | Devices |
| Products | Radio-Capitellum, Capitellum, Left, Large, Do Not Reuse, Rx Only. Indicated for use in the elbow for reduction or relief of pain and/or improved elbow function in skeletally mature patients., Recon, Radial Implant, Standard Stem, Size 1, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the proximal end of the radius., rHead Lateral Stem, Size 1, Do Not Reuse, Sterile. Intended for replacement of the proximal end of the radius., Sigmoid Notch, Radial Plate, Small, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the distal radio-ulnar joint following ulnar head resection arthroplasty., uHead, Ulnar Implant, Standard Stem, Size 1, Sterile, Rx Only. Intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may potentially be compromised by transportation. |
| Initiation date | Jun 24, 2015 |
| Report date | Aug 26, 2015 |
| Termination date | Apr 29, 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: