FDA recall Z-0929-2021

Neocis, Inc. · Class II · device

Product

DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (NGS)

Reason for recall

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

Distribution

OH, FL, CT, MA, AZ PA, NY

Key facts

Status
Terminated
Initiation date
2020-10-30
Report date
2021-02-03
Termination date
2021-08-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Miami, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0929-2021