Z-1360-2018 Class II Terminated
FDA device recall Z-1360-2018 was initiated by Zimmer GmbH on Mar 15, 2018 and is designated Class II. 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. The recall status is terminated (terminated Apr 25, 2019).
Recall Details
- Product Type
- Devices
- Report Date
- Apr 18, 2018
- Initiation Date
- Mar 15, 2018
- Termination Date
- Apr 25, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1360-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026