EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly connected to the endosseous d
FDA device recall Z-0029-05 · posted 2004-10-21 · Terminated
Recall details
- Recalling firm
- Implant Innovations, Inc.
- Reason for recall
- The nylon bag holding the product was not completely sealed before sterilization. Patients could be infected if the abutment is implanted.
- Action taken
- Begining on October 4, 2004 each direct account was contacted by email, faxed letter and telephone. They were informed of the recall and instructed to contact their customers if the product had been sold.
- Root cause
- Other
- Status
- Terminated
- Product code
- DZE
- Quantity affected
- 216 units
- Distribution
- Distributed to 34 direct accounts throughout the United States and four international accounts in Europe, Asia, South America and the middle East.
- Date initiated
- 2004-10-04
- Date posted
- 2004-10-21
- Date terminated
- 2005-02-07
- 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 |