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Class 3 Device Recall MEDPOR Surgical Implant, Catalog 6317, 20mm Sphere |
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Date Initiated by Firm |
March 07, 2005 |
Date Posted |
April 16, 2005 |
Recall Status1 |
Terminated 3 on August 17, 2005 |
Recall Number |
Z-0712-05 |
Recall Event ID |
31604 |
510(K)Number |
K863943
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Product Classification |
Implant, Eye Sphere - Product Code HPZ
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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 |
Recalling Firm/ Manufacturer |
Porex Surgical, Inc. 15 Dart Rd Newnan GA 30265-1017
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For Additional Information Contact |
Jerry Davis 770-515-7735
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Manufacturer Reason for Recall |
The product, which is a 20mm MEDPOR Sphere, was mislabeled in that the package contained 18mm MEDPOR Spheres
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FDA Determined Cause 2 |
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
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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.
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510(K) Database |
510(K)s with Product Code = HPZ and Original Applicant = POREX MEDICAL
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