LOCATOR Restorative Abutment, ILOA002, LOT 877423, Certain LOCATOR ABUTMENT, 4.1 mm(D) X 2mm(H), STERILE Made in USA, St
FDA device recall Z-0810-2010 · posted 2010-02-22 · Terminated
Recall details
- Recalling firm
- Biomet 3i, LLC
- Reason for recall
- Package labeled as sterile may have an incomplete or partial seal thereby possibly compromising sterility.
- Action taken
- Each US customer will be contacted by telephone using a prepared phone script. Following telephone contact, Biomet 3i will perform a follow-up of each call with a faxed letter. The Urgent: Medical Device Recall letter, dated 11/23/2009, identified the affected product and asked customers to return unused product for replacement. The letter also explained the clinical implications and asked customers to respond with the attached response fax and then return the abutment(s) to BIOMET 3i. Questions or concerns can be directed to Kelly Taylor at 561-776-6906.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DZE
- Quantity affected
- 97
- Distribution
- Worldwide Distribution -- USA, Middle East, Italy, Europe, and Greece.
- Date initiated
- 2009-11-23
- Date posted
- 2010-02-22
- Date terminated
- 2010-12-15
- 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 |
|---|---|---|
| 3I LOCATER ABUTMENT SYSTEM (K012911) | Implant Innovations, Inc. | 2001-09-28 |