FDA Recall
Terminated
Normed Charcot Osteotome Chisel (Various sizes)
Recall: Z-1360-2018
·
Initiated March 15, 2018
Recall
- Recall Number
- Z-1360-2018
- Event Number
- 79495
- Firm
- Zimmer GmbH Sulzerallee 8 Winterthur Switzerland
- FEI Number
- 3005233524
- Product Code
- KDG
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- March 15, 2018
- Terminated
- April 25, 2019
Description
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.
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