Recall Z-1360-2018 ยท KDG Chisel (Osteotome)
Zimmer GmbH
Normed Charcot Osteotome Chisel (Various sizes)
| Date | Mar 15, 2018 |
| Status | Terminated |
| 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. |
| Distribution | CO, IN, TX, IL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.