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
FDA Recall Z-0712-05 · Posted 2005-04-16
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Recalling FirmPorex Surgical, Inc.
Recall StatusTerminated
Product CodeHPZ
Date Initiated2005-03-07
Date Terminated2005-08-17
Product Quantity30 units
Reason for Recall
The product, which is a 20mm MEDPOR Sphere, was mislabeled in that the package contained 18mm MEDPOR Spheres
Firm Action
On 03/07/2005 and 03/08/2005 consignees were notified via email and telephone. A follow up letter was being sent.
Root Cause
Other
Distribution Pattern
AZ, IL, NJ and Korea
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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