CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number IEDAN3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
This recall has been terminated (originally issued February 26, 2019).
- Company
- Biomet 3I, Llc
- Recall Initiated
- February 26, 2019
- Terminated
- June 15, 2020
- Recall Number
- Z-2140-2019
- Quantity
- 3 units
- Firm Location
- Palm Beach Gardens, FL
- Official Source
- View on FDA website ↗
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
Nationwide and Puerto Rico, Canada, and Australia
Lot / Code Info
Lot Numbers/UDI: 8442784-1/(01)00844868031130(10)8442784-1, 8442469-1/(01)00844868031130(10)8442469-1, 8442689-1/(01)00844868031130(10)8442689-1
Root Cause
Process control
Action Taken
The firm disseminated the notices by email on 02/26/2019. The letter requested that the dental laboratories quarantine and return any unused product and to further notify the affected clinician referral.