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Terminated

Normed Charcot Osteotome Chisel (Various sizes)

FDA Recall Z-1360-2018 · Posted None

Recalling FirmZimmer GmbH
Recall StatusTerminated
Product CodeKDG
Date Initiated2018-03-15
Date Terminated2019-04-25

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.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

CO, IN, TX, IL

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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