FDA recall Z-1360-2018

Product

Normed Charcot Osteotome Chisel (Various sizes)

Reason for recall

Product may contain a gap between the handle and metal chisel which can lead to failure to properly disinfect or sterilize between use.

Distribution

CO, IN, TX, IL

Key facts

Status

Terminated

Initiation date

2018-03-15

Report date

2018-04-18

Termination date

2019-04-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Winterthur, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1360-2018