FDA recall Z-0349-2020

Product

MODIFIED INSTRUMENTS: Trial Spacer 7mm with T-Handle Trial Spacer 8mm with T-Handle Trial Spacer 9mm with T-Handle Trial Spacer 10mm with T-Handle Trial Spacer 11mm with T-Handle Trial Spacer 12mm with T-Handle Trial Spacer 13mm with T-Handle Trial Spacer 15mm with T-Handle Trial Spacer 17mm with T-Handle

Reason for recall

Modified outside of approved manufacturing process

Distribution

AR

Key facts

Status

Terminated

Initiation date

2019-09-05

Report date

2019-11-20

Termination date

2020-06-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

West Chester, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0349-2020