Integrated Orbital Implants Inc Bio-Eye Hydroxyapatite (HA) Orbital Implant and Conformer, Model Number: 100020S Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Bio-Eye Hydroxyapatite (HA) Orbital Implant and Conformer, Model Number: 100020S
Brand
Integrated Orbital Implants Inc
Lot Codes / Batch Numbers
Lot/Unit Codes: 976115CC, Serial Numbers: 2000509, 207025, 207557, 44993, 62774, 205928, 201933, 203550, 205927, 202939
Products Sold
Lot/Unit Codes: 976115CC, Serial Numbers: 2000509, 207025, 207557, 44993, 62774, 205928, 201933, 203550, 205927, 202939
Integrated Orbital Implants Inc is recalling Bio-Eye Hydroxyapatite (HA) Orbital Implant and Conformer, Model Number: 100020S due to 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 la. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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''.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026