FDA Medical Device Recalls (openFDA)
Integrated Orbital Implants Inc: Bio-Eye Hydroxyapatite (HA) Orbital Implant and Conformer, Model Number: 100020S
- Recall number
- Z-0012-2007
- Recalling firm
- Integrated Orbital Implants Inc
- Product
- Bio-Eye Hydroxyapatite (HA) Orbital Implant and Conformer, Model Number: 100020S
- Status
- Terminated
- Initiated
- 2006-02-27
- Posted
- 2006-10-04
- Terminated
- 2006-10-05
- Reason
- 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''.
- Root cause
- Other
- Action
- 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.
- Quantity
- 8
- Distribution
- Internationally to Finland & France
- Lot, serial or model codes
- Lot/Unit Codes: 976115CC, Serial Numbers: 2000509, 207025, 207557, 44993, 62774, 205928, 201933, 203550, 205927, 202939
- 510(k) numbers
- ["K982562"]
- PMA numbers
- not on file
- Product code
- HPZ
- Firm FEI
- 3009688114
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28