Sterile Bio-Eye Hydroxyapatite Orbital Implant and Conformer
FDA device recall Z-2292-2010 · posted 2010-08-26 · Terminated
Recall details
- Recalling firm
- Integrated Orbital Implants Inc
- Reason for recall
- Integrated Orbital Implants, Inc. has initiated a recall of it's Sterile Bio-Eye Hydroxyapatite Orbital Implant and Conformer due to a labeling issue in which the expiration date of the product was omitted.
- Action taken
- Customers were contacted by telephone and email
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- HPZ
- Quantity affected
- 40 units
- Distribution
- USA (MT, AL, IN, IA, NY, KY, IL, MI, and FL), Canada, Germany, and Turkey
- Date initiated
- 2010-06-07
- Date posted
- 2010-08-26
- Date terminated
- 2010-08-31
- 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 |