Recall Z-1360-2018— Zimmer GmbH
Class II · Terminated
Class II FDA medical device recall by Zimmer GmbH, initiated 2018-03-15, terminated 2019-04-25. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Zimmer GmbH
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-03-15
- Terminated
- 2019-04-25
- Firm location
- Winterthur, Switzerland
Product description
Normed Charcot Osteotome Chisel (Various sizes)
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.