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U.S. Department of Health and Human Services

Class 3 Device Recall BioEye

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 Class 3 Device Recall BioEyesee related information
Date Initiated by FirmFebruary 27, 2006
Date PostedOctober 04, 2006
Recall Status1 Terminated 3 on October 05, 2006
Recall NumberZ-0012-2007
Recall Event ID 36298
510(K)NumberK982562 
Product Classification orbital implant - Product Code HPZ
ProductBio-Eye Hydroxyapatite (HA) Orbital Implant and Conformer, Model Number: 100020S
Code Information Lot/Unit Codes: 976115CC, Serial Numbers: 2000509, 207025, 207557, 44993, 62774, 205928, 201933, 203550, 205927, 202939
Recalling Firm/
Manufacturer		 Integrated Orbital Implants Inc
12625 High Bluff Dr Ste 314
San Diego CA 92130-2054
For Additional Information ContactNatalie J. Kennel
858-705-0350
Manufacturer Reason
for Recall		The end label on the outer box was mislabeled on 9 of a 10 unit lot. The end label says ''22 mm'' and the implants are actually ''20 mm''. The main label on the cardboard box applied by the contract packager is correct in identifying the product as ''20 mm''.
FDA Determined
Cause 2		Other
ActionThe recall was to the distributor level. From contact with the two distributors involved, it was determined that all of the product affected was still with the two distributors. Both distributors affected were notified via email 2/27/2006. The correct labels were shipped by FEDEX to each of them. Both distributors were instructed to check their inventory of this lot number and confirm if the end labels were in conflict with the main outer box label. When this was confirmed, the distributor was instructed to apply the correct end labels supplied.
Quantity in Commerce8
DistributionInternationally to Finland & France
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = HPZ
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