Z-1360-2018 Class II Terminated
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