EP Healing abutment- Product Code-ITHA52-a pre-manufactured prosthetic component directly connected to an endosseous den
FDA device recall Z-0922-2007 · posted 2007-06-14 · Terminated
Recall details
- Recalling firm
- Biomet 3i
- Reason for recall
- Package Integrity; sterility compromised-Incomplete seals on the nylon bags in which the product is packed.
- Action taken
- Each consignee will be contacted by email or telephone followed by a faxed letter. Each consignee was instructed to check their respective inventory for the recalled part and corresponding lot number. They were directed to return the product to the recalling firm.
- Root cause
- Other
- Status
- Terminated
- Product code
- DZE
- Distribution
- Worldwide.
- Date initiated
- 2006-10-16
- Date posted
- 2007-06-14
- Date terminated
- 2008-12-30
- Location
- Palm Beach Gardens, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ONE AND TWO PIECE TEMPORARY HEALING,(EMERGENCE PROFILE) ABUTMENTS (K934126) | Implant Innovations, Inc. | 1994-04-25 |