Z-0712-05

MEDPOR Surgical Implant * POREX Surgical Products Group * Sterile/EO * Implant, Non-Pyrogenic, For Single Use...

Name: Z-0712-05 MEDPOR Surgical Implant * POREX Surgical Products Group * Sterile/EO * Implant, Non-Pyrogenic, For Single Use...
Creator: Porex Surgical, Inc.
Published: 2005-03-07
License: https://open.fda.gov/license/

Porex Surgical, Inc. / initiated 2005-03-07 / Terminated / root cause: labeling and UDI

FDA source

Porex Surgical, Inc. began a recall of MEDPOR Surgical Implant * POREX Surgical Products Group * Sterile/EO * Implant, Non-Pyrogenic, For Single Use Only, CAT #6317 DIM 20mm Diameter * Lot xxxxxx *... on 2005-03-07. The reason FDA records is "The product, which is a 20mm MEDPOR Sphere, was mislabeled in that the package contained 18mm MEDPOR Spheres". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0712-05
Status: Terminated
Initiated: 2005-03-07
Posted: 2005-04-16
Terminated: 2005-08-17
Recalling firm: Porex Surgical, Inc.
Product: MEDPOR Surgical Implant * POREX Surgical Products Group * Sterile/EO * Implant, Non-Pyrogenic, For Single Use Only, CAT #6317 DIM 20mm Diameter * Lot xxxxxx * QTY: 1 * Porex Surgical Inc., 15 Dart Road, Newnan, GA 30265 USA
Product code: HPZ Implant, Eye Sphere
Reason for recall: The product, which is a 20mm MEDPOR Sphere, was mislabeled in that the package contained 18mm MEDPOR Spheres
Root cause tag: labeling and UDI
FDA root cause: Other
Action: On 03/07/2005 and 03/08/2005 consignees were notified via email and telephone. A follow up letter was being sent.
Quantity in commerce: 30 units
Distribution: AZ, IL, NJ and Korea
Product codes and lots: Lot A004A02

Product code HPZ

K863943Class IIPorex(tm) Eye Sphere ImplantPorex Medical / cleared 1987-02-27

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)