FDA Recall
Terminated
UCLA Abutment Hexed Castable Cylinder 3.4mm Are accessories to endosseous dental implant to support a prosthetic device in a partially or completely edentulous patient.
Recall: Z-2760-2015
·
Initiated July 29, 2015
Recall
- Recall Number
- Z-2760-2015
- Event Number
- 72000
- Firm
- Biomet 3i, LLC
- FEI Number
- 1038806
- Product Code
- NHA
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- July 29, 2015
- Posted
- September 11, 2015
- Terminated
- May 16, 2016
- Address
- 4555 Riverside Dr, Palm Beach Gardens, FL, 33410-4200
Description
UCLA Abutment Hexed Castable Cylinder 3.4mm Are accessories to endosseous dental implant to support a prosthetic device in a partially or completely edentulous patient.
Reason
MUCC2, non-hexed, castable abutment cylinders, has been labeled and distributed as a MUCC1C, hexed, castable abutment cylinders for this one lot only.
Action
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
Distribution
Worldwide Distribution including Italy and Uruguay.
Quantity
61 pieces