3i Custom # 5753, OSCM2913, 2.9MMX 3.4MM X 13MM, OSSEOTITE CUSTOM, MICROMINI IMPLANT, LOT # 470258, Sterile. Implant Inn
FDA device recall Z-2227-2009 · posted 2009-09-22 · Terminated
Recall details
- Recalling firm
- Biomet 3i, LLC
- Reason for recall
- Healing Abutment was not made within required manufacturing specification. The product did not have the relief behind the thread, which does not allow proper seating.
- Action taken
- Each of the US customers was contacted by phone. Following the phone contacts, Biomet 3i performed a follow- up of each call with a faxed letter. Each customer was instructed to check their respective inventory for the affected product and corresponding lot number. They were then requested to fax back a response form to Biomet 3i Regulatory Services to provide feedback concerning their inventory. They were also instructed to return the affected product to Biomet 3i. Contact Biomet 3i, LLC at 1.561.776.6706, if there are any questions.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- NDA
- Quantity affected
- 24
- Distribution
- USA and Italy
- Date initiated
- 2006-12-11
- Date posted
- 2009-09-22
- Date terminated
- 2009-10-01
- 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 |
|---|---|---|
| BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS (K072642) | Biomet 3i, Inc. | 2007-12-20 |