FDA recall Z-2639-2020

Product

DRW-0742-01: Gen 2 Anterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.

Reason for recall

The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled.

Distribution

US Nationwide distribution including in the states of AZ, CA, FL, NY, and NH

Key facts

Status

Terminated

Initiation date

2020-05-14

Report date

2020-07-22

Termination date

2021-07-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Miami, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2639-2020