Recall Z-1360-2018
Zimmer GmbH · initiated March 15, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Normed Charcot Osteotome Chisel (Various sizes)
Codes / 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
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.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-1360-2018
- Initiated
- March 15, 2018
- Terminated
- April 25, 2019
- Product code
- KDG – Chisel (Osteotome)
- Distribution
- CO, IN, TX, IL
- Recalling firm
- Zimmer GmbH, Winterthur