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.
FDA Recall Z-1435-2012 · Posted 2012-04-18
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Recalling FirmHowmedica Osteonics Corp dba Stryker Craniomaxillofacial
Recall StatusTerminated
Product CodeHPZ
Date Initiated2012-03-20
Date Terminated2012-08-10
Product Quantity31 units
Reason for Recall
The MEDPOR PLUS SST EZ 22mm sphere implants are not within specification of 22mm +/- 8, therefore implant is not easily released from the syringe.
Firm 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.
Root Cause
Process control
Distribution Pattern
US Distribution, the state of Michigan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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