Medical device recalls Moderate risk

Synthes (USA) Products LLC recalls Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible shafts are intended for use as an optional r…

Recall date
October 31, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0656-2017
FDA classification
Class II
Brand / firm
Synthes (USA) Products LLC
Sold / distributed
US Nationwide Distribution.

Why it was recalled

Non-conforming material used.

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

What was recalled

Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible shafts are intended for use as an optional reaming step in intramedullary nailing systems.

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