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U.S. Department of Health and Human Services

Class 3 Device Recall Sterile BioEye Hydroxyapatite Orbital Implant and Conformer

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  Class 3 Device Recall Sterile BioEye Hydroxyapatite Orbital Implant and Conformer see related information
Date Initiated by Firm June 07, 2010
Date Posted August 26, 2010
Recall Status1 Terminated 3 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 2
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 and Original Applicant = INTEGRATED ORBITAL IMPLANTS, INC.
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