Medical device recalls Moderate risk

Synthes (USA) Products LLC recalls 2.5 mm Guide Rod w/Smooth Tip 950 mm, Sterile

Recall date
October 3, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0641-2017
FDA classification
Class II
Brand / firm
Synthes (USA) Products LLC
Sold / distributed
Distributed Nationwide

Why it was recalled

The peel pouches for the affected reaming rods and extraction hooks are delaminating.

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

What was recalled

2.5 mm Guide Rod w/Smooth Tip 950 mm, Sterile

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