Recalls / —
—#139565
Product
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.
- FDA product code
- NHA — Abutment, Implant, Dental, Endosseous
- Device class
- Class 2
- Medical specialty
- Dental
- 510(k) numbers
- K072642
- Affected lot / code info
- Model # MUCC1C LOT # 1186054
Why it was recalled
MUCC2, non-hexed, castable abutment cylinders, has been labeled and distributed as a MUCC1C, hexed, castable abutment cylinders for this one lot only.
Root cause (FDA determination)
Process control
Action the firm took
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
Recalling firm
- Firm
- Biomet 3i, LLC
- Address
- 4555 Riverside Dr, Palm Beach Gardens, Florida 33410-4200
Distribution
- Distribution pattern
- Worldwide Distribution including Italy and Uruguay.
Timeline
- Recall initiated
- 2015-07-29
- Posted by FDA
- 2015-09-11
- Terminated
- 2016-05-16
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #139565. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.