FDA Device recall Z-1360-2018
Normed Charcot Osteotome Chisel (Various sizes)
- FDA Device
- Class II
- terminated
- Published 2018-04-18
On 2018-04-18 the FDA classified a Class II recall of Normed Charcot Osteotome Chisel (Various sizes) by Zimmer, citing product may contain a gap between the handle and metal chisel which can lead to failure to properly disinfect or sterilize between use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1360-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-03-15 |
| Published | 2018-04-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer |
| Distribution | CO, IL, IN, TX |
Product
Normed Charcot Osteotome Chisel (Various sizes)
Reason
Product may contain a gap between the handle and metal chisel which can lead to failure to properly disinfect or sterilize between use.
Identifiers
| code_info | 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…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1360-2018%22
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