Recall Z-1435-2012 ยท HPZ Implant, Eye Sphere
Howmedica Osteonics Corp dba Stryker Craniomaxillofacial
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.
| Date | Apr 18, 2012 (initiated Mar 20, 2012) |
| Status | Terminated |
| Reason | The MEDPOR PLUS SST EZ 22mm sphere implants are not within specification of 22mm +/- 8, therefore implant is not easily released from the syringe. |
| Root cause | Process control |
| Action | The sole distributor was notified by "Urgent Product Recall" letter on March 20, 2012. "Urgent Medical Device Recall" letters were sent to Stryker Customers on March 26, 2012. The letters described the product issue, hazards, and actions recommended to mitigate the risk. Customer number provided: (800) 962-6558. |
| Quantity | 31 units |
| Distribution | US Distribution, the state of Michigan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021357 | MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT Porex Surgical, Inc., Aug 5, 2002 |