Z-1360-2018 Class II Terminated

Recalled by Zimmer GmbH — Winterthur

Recall Details

Product Type
Devices
Report Date
April 18, 2018
Initiation Date
March 15, 2018
Termination Date
April 25, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

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 Pattern

CO, IN, TX, IL

Code Information

Models: 26.08.506 OSTEO 8MM AND W/HDL 20CM/8IN 26.08.507 OSTEO 10MM AND W/HDL 20CM/8IN 26.08.508 OSTEO 12MM AND W/HDL 20CM/8IN 26.08.509 OSTEO 13MM CRVD R 10 23CM/9IN 26.08.619 OSTEO 19MM CRVD R 10 23CM/9IN (No US distribution) 26.08.712 OSTEO 12MM CRVD R 6 23CM/9IN (No US distribution) 26.08.715 OSTEO 15MM CRVD R 6 23CM/9IN (No US distribution) 26.08.718 CHARC OSTE 18MM CRD R6 23CM/9 26.08.812 OSTEO 12MM CRVD R 8 23CM/9IN (No US distribution) 26.08.815 OSTEO 15MM CRVD R 8 23CM/9IN (No US distribution) 26.08.818 CHARC OSTE 18MM CRD R8 23CM/9 (No US distribution) 26.08.900 ARTHROPIC ARTH 18CM 45TUFF HDL 26.08.910 RUTREK CHIS 20CM/8 DBL CUT BLD