Bio-Eye Hydroxyapatite (HA) Orbital Implant and Conformer, Model Number: 100020S
FDA device recall Z-0012-2007 · posted 2006-10-04 · Terminated
Recall details
- Recalling firm
- Integrated Orbital Implants Inc
- 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 taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- HPZ
- Quantity affected
- 8
- Distribution
- Internationally to Finland & France
- Date initiated
- 2006-02-27
- Date posted
- 2006-10-04
- Date terminated
- 2006-10-05
- Location
- San Diego, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER (K982562) | Integrated Orbital Implants, Inc. | 1998-12-28 |