Z-0349-2020 Class II Terminated

Recalled by Synthes (USA) Products LLC — West Chester, PA

Recall Details

Product Type
Devices
Report Date
November 20, 2019
Initiation Date
September 5, 2019
Termination Date
June 23, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9 units

Product Description

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 Pattern

AR

Code Information

Unknown