Medical device recalls Moderate risk

Zimmer GmbH recalls Normed Charcot Osteotome Chisel (Various sizes)

Recall date
March 15, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1360-2018
FDA classification
Class II
Brand / firm
Zimmer GmbH
Sold / distributed
CO, IN, TX, IL

Why it was recalled

Product may contain a gap between the handle and metal chisel which can lead to failure to properly disinfect or sterilize between use.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Normed Charcot Osteotome Chisel (Various sizes)

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