Z-2143-2019 Class II Terminated
FDA device recall Z-2143-2019 was initiated by Biomet 3i, LLC on February 26, 2019 and is designated Class II. Reason for recall: During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop. The recall status is terminated (terminated June 15, 2020). Affected quantity: 2 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 14, 2019
- Initiation Date
- February 26, 2019
- Termination Date
- June 15, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units
Product Description
CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number ILDAN3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
Reason for Recall
During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.
Distribution Pattern
Nationwide and Puerto Rico, Canada, and Australia
Code Information
Lot Numbers/UDI: 8442561-2/(01)00844868031352(10)8442561-2 8442561-3/(01)00844868031352(10)8442561-3