FDA recall Z-1321-2024

Product

Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967

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.

Key facts

Status

Ongoing

Initiation date

2024-02-09

Report date

2024-03-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Santa Maria, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1321-2024