Z-1435-2012

MEDPOR PLUS SST EZ 22mm Sphere Implant, Howmedica Osteonics Corp, 15 Dart Road, Newnan, GA 30265. MEDPOR PLUS...

Name: Z-1435-2012 MEDPOR PLUS SST EZ 22mm Sphere Implant, Howmedica Osteonics Corp, 15 Dart Road, Newnan, GA 30265. MEDPOR PLUS...
Creator: Howmedica Osteonics Corp dba Stryker Craniomaxillofacial
Published: 2012-03-20
License: https://open.fda.gov/license/

Porex Surgical, Inc. / initiated 2012-03-20 / Terminated / root cause: manufacturing process

FDA source

Howmedica Osteonics Corp dba Stryker Craniomaxillofacial began a recall of 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... on 2012-03-20. The reason FDA records is "The MEDPOR PLUS SST EZ 22mm sphere implants are not within specification of 22mm +/- 8, therefore implant is not easily released from the syringe". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1435-2012
Status: Terminated
Initiated: 2012-03-20
Posted: 2012-04-18
Terminated: 2012-08-10
Recalling firm: Porex Surgical, Inc.
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 Implant, Eye Sphere
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 31 units
Distribution: US Distribution, the state of Michigan.
Product codes and lots: Catalog number: 80062, Lot Codes: F000689 and G004528.

Product code HPZ

K021357Class IIMedpor Plus Orbital Volume Replacement ImpantPorex Surgical, Inc. / cleared 2002-08-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)