Class 3 Device Recall Sterile BioEye Hydroxyapatite Orbital Implant and Conformer

• Date Initiated by Firm: June 07, 2010
• Date Posted: August 26, 2010
• Recall Status: Terminated on August 31, 2010
• Recall Number: Z-2292-2010
• Recall Event ID: 56329
• 510(K)Number: K982562
• Product Classification: Implant, Eye Sphere - Product Code HPZ
• Product: Sterile Bio-Eye Hydroxyapatite Orbital Implant and Conformer
• Code Information: Lot# 528020R - Serial Numbers: 55839, 60778, 60848, 60957, 61391, 170021, 185765, 185766, 185768, 185769, 185946, 190014, 190015, 190018, 2004053, 2004578, 209584, 209585, 209586, 209587, 209611, 209627, 209628, 209629, 209631, 170022, 170023, 190019, 190021, 190025, 220048, 222535, 53049, 62327, 223207, 240031, 240032, 240039, 240040, 240048
• Recalling Firm/ Manufacturer: Integrated Orbital Implants Inc; 12625 High Bluff Dr Ste 300; San Diego CA 92130-2054
• For Additional Information Contact: 858-259-4355
• Manufacturer Reason for Recall: 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 of the product was omitted.
• FDA Determined Cause: Error in labeling
• Action: Customers were contacted by telephone and email
• Quantity in Commerce: 40 units
• Distribution: USA (MT, AL, IN, IA, NY, KY, IL, MI, and FL), Canada, Germany, and Turkey
• 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