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Orbtex Orbital Implant
CERAMISYS LTD · Model RPX18 · UDI-DI 05060171621973
HPZ
Prescription
1
510(k) clearances
33
Adverse events
4
Recalls
19
Facilities
Description
Porous alumina orbital implant with suture platform, sphere, 18mm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2012-03-20 | Howmedica Osteonics Corp dba Stryker Craniomaxillofacial | The MEDPOR PLUS SST EZ 22mm sphere implants are not within specification of 22mm +/- 8, therefore implant is not easily released from the syringe. |
| 2010-06-07 | Integrated Orbital Implants Inc | Integrated Orbital Implants, Inc. has initiated a recall of it's Sterile Bio-Eye Hydroxyapatite Orbital Implant and Conformer due to a labeling issue in which the expiration date o |
| 2006-02-27 | Integrated Orbital Implants Inc | The end label on the outer box was mislabeled on 9 of a 10 unit lot. The end label says ''22 mm'' and the implants are actually ''20 mm''. The main label on the cardboard box appli |
| 2005-03-07 | Porex Surgical, Inc. | The product, which is a 20mm MEDPOR Sphere, was mislabeled in that the package contained 18mm MEDPOR Spheres |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.