FDA Recall
Terminated
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.
Recall: Z-1435-2012
·
Initiated March 20, 2012
Recall
- Recall Number
- Z-1435-2012
- Event Number
- 61620
- Firm
- Howmedica Osteonics Corp dba Stryker Craniomaxillofacial
- FEI Number
- 1000131961
- Product Code
- HPZ
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- March 20, 2012
- Posted
- April 18, 2012
- Terminated
- August 10, 2012
- Address
- 15 Dart Rd, Newnan, GA, 30265-1017
Description
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.
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.
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.
Distribution
US Distribution, the state of Michigan.
Quantity
31 units