Device recall
Z-1435-2012: MEDPOR PLUS SST EZ 22mm Sphere Implant, Howmedica Osteonics Corp, 15 Dart Road…
FDA device recall · Class II · Howmedica Osteonics Corp dba Stryker Craniomaxillofacial
Key facts
| Recall number (Z-number) | Z-1435-2012 |
|---|---|
| Recall event | 61620 |
| Product | MEDPOR PLUS SST EZ 22mm Sphere Implant, Howmedica Osteonics Corp, 15 Dart Road, Newnan, GA 30265. MEDPOR PLUS Orbital Implants are intended to restore the volume of an enucleated or eviscerated eye globe. |
| Product code | HPZ |
| Recalling firm | Howmedica Osteonics Corp dba Stryker Craniomaxillofacial |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 10, 2012 |
| 510(k) numbers | K021357 |
| FEI number | 1000131961 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database