Class 3 Device Recall MEDPOR Surgical Implant, Catalog 6317, 20mm Sphere

• Date Initiated by Firm: March 07, 2005
• Date Posted: April 16, 2005
• Recall Status: Terminated on August 17, 2005
• Recall Number: Z-0712-05
• Recall Event ID: 31604
• 510(K)Number: K863943
• Product Classification: Implant, Eye Sphere - Product Code HPZ
• 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
• Code Information: Lot A004A02
• FEI Number: 1000131961
• Recalling Firm/ Manufacturer: Porex Surgical, Inc.; 15 Dart Rd; Newnan GA 30265-1017
• For Additional Information Contact: Jerry Davis; 770-515-7735
• Manufacturer Reason for Recall: The product, which is a 20mm MEDPOR Sphere, was mislabeled in that the package contained 18mm MEDPOR Spheres
• FDA Determined 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = HPZ