FDA-Device2019-11-20Class II
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
Synthes (USA) Products LLC
Hazard
Modified outside of approved manufacturing process
Sold states
AR
Affected count
9 units
Manufactured in
1301 Goshen Pkwy, N/A, West Chester, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0349-2020Don't want to check this manually?
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