Medical device recalls Moderate risk

Synthes (USA) Products LLC recalls 11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile

Recall date
July 21, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0604-2018
FDA classification
Class II
Brand / firm
Synthes (USA) Products LLC
Sold / distributed
TX, GA, PA, UT and Canada

Why it was recalled

The locking mechanism and protective cap were missing from the sterile packed nails of the affected lot.

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

What was recalled

11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile

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