FDA Medical Device Recalls (openFDA)
Zimmer GmbH: Normed Charcot Osteotome Chisel (Various sizes)
- Recall number
- Z-1360-2018
- Recalling firm
- Zimmer GmbH
- Product
- Normed Charcot Osteotome Chisel (Various sizes)
- Status
- Terminated
- Initiated
- 2018-03-15
- Posted
- not on file
- Terminated
- 2019-04-25
- Reason
- 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
- 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.
- Quantity
- not on file
- Distribution
- CO, IN, TX, IL
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KDG
- Firm FEI
- 3005233524
- Firm city
- Winterthur
- Firm state
- not on file
- Firm country
- Switzerland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28