FDA recall Z-2638-2020

Neocis Inc. · Class II · device

Product

DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left) - 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-2638-2020