Z-1360-2018Class II

Normed Charcot Osteotome Chisel (Various sizes)

Name: Z-1360-2018 Normed Charcot Osteotome Chisel (Various sizes)
Creator: Zimmer GmbH
Published: 2018-03-15
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2018-03-15 / Terminated / root cause: sterility

FDA source

Zimmer GmbH began a recall of Normed Charcot Osteotome Chisel (Various sizes) on 2018-03-15. FDA classified it as Class II and gives the reason as "Product may contain a gap between the handle and metal chisel which can lead to failure to properly disinfect or sterilize between use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1360-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-15
Posted: 2018-04-11
Terminated: 2019-04-25
Recalling firm: Zimmer GmbH
Product: Normed Charcot Osteotome Chisel (Various sizes)
Product code: KDG Chisel (Osteotome)
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.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: On March 15, 2018 an URGENT MEDICAL DEVICE RECALL LETTER was issued to affected hospitals with the following instructions: 1. Review this notification for awareness of the contents. 2. Assist your Zimmer Biomet sales representative to quarantine immediately all affected instruments. 3. Your Zimmer Biomet sales representative will remove the affected instruments from your facility Questions or concerns can be directed to a zimmer biomet representative.
Distribution: CO, IN, TX, IL
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1360-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1360-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-04-11

Product code KDG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)