UCLA Abutment Hexed Castable Cylinder 3.4mm Are accessories to endosseous dental implant to support a prosthetic device
FDA device recall Z-2760-2015 · posted 2015-09-11 · Terminated
Recall details
- Recalling firm
- Biomet 3i, LLC
- Reason for recall
- MUCC2, non-hexed, castable abutment cylinders, has been labeled and distributed as a MUCC1C, hexed, castable abutment cylinders for this one lot only.
- Action taken
- Biomet sent a Medical Device Recall Notice dated July 27, 2015, to all their clinicians informing them about the recall and to complete the attached recall return response form and any unused product to be replaced at no charge. Contact information 1-800-342-5454
- Root cause
- Process control
- Status
- Terminated
- Product code
- NHA
- Quantity affected
- 61 pieces
- Distribution
- Worldwide Distribution including Italy and Uruguay.
- Date initiated
- 2015-07-29
- Date posted
- 2015-09-11
- Date terminated
- 2016-05-16
- Location
- Palm Beach Gardens, FL
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS (K072642) | Biomet 3i, Inc. | 2007-12-20 |