FDA Device Recall Z-0012-2007: Integrated Orbital Implants Inc

Recall Res Number

Z-0012-2007

Recalling Firm / Manufacturer

Integrated Orbital Implants Inc

FEI Number

3009688114

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2006-02-27

Date Posted

2006-10-04

Date Terminated

2006-10-05

Product Code

HPZ

Event Number

36298

Product Quantity

8

Product Description Bio-Eye Hydroxyapatite (HA) Orbital Implant and Conformer, Model Number: 100020S

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''.

Action Details The 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.

Distribution Pattern Internationally to Finland & France

Code Information / Serial Numbers Lot/Unit Codes: 976115CC, Serial Numbers: 2000509, 207025, 207557, 44993, 62774, 205928, 201933, 203550, 205927, 202939

STERLAB Registration: 1000286794 View Registration
Sterigenics U.S., LLC Registration: 1018470 View Registration
Sterigenics US LLC Registration: 1058584 View Registration
FCI OPHTHALMICS, INC. Registration: 1225124 View Registration
INTEGRATED ORBITAL IMPLANTS, INC. Registration: 2027377 View Registration
ARMM, INC. Registration: 2028523 View Registration
STALLION MEDICAL, INC. Registration: 2031962 View Registration
KATENA PRODUCTS, INC. Registration: 2242450 View Registration
Sterigenics U.S., LLC Registration: 2245590 View Registration
GULDEN OPHTHALMICS Registration: 2518410 View Registration
FCI FRANCE CHIRURGIE INSTRUMENTATION Registration: 3002991496 View Registration
MILLENNIUM SURGICAL CORP Registration: 3004215117 View Registration
FCI SUD Registration: 3004467263 View Registration
Ambler Surgical, LLC Registration: 3005528784 View Registration
CERAMISYS LTD Registration: 3007708799 View Registration
Synergy Health Marseille SAS Registration: 3010162973 View Registration
KATENA PRODUCTS, INC. Registration: 3015177648 View Registration
STRYKER LEIBINGER GMBH & CO. KG Registration: 8010177 View Registration
FCI SAS Registration: 9615745 View Registration

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Medical Device Recall: Z-0012-2007

Recall Parameters & Description

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