Due to a manufacturing issue, the screw seat location on the abutment product may be too high, causing mating screw to have a shorter engagement length into the associated implant.
Reason for recall: Due to a manufacturing issue, the screw seat location on the abutment product may be too high, causing mating screw to have a shorter engagement length into the associated implant. Distribution: U.S. Nationwide distribution in the states of AZ, OH and PA. Quantity: 561 units Lot/code info: Model Number: 9000967 UDI-DI code: 00842092165867 Lot Numbers: 235650, 234294, 233667, 233885, 233439, and 231489
00842092165867
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.