Medical device recalls Moderate risk

Symmetry Surgical, Inc. recalls symmetry surgical ULTRA(R) Steam container, REF numbers: C131310, C13134, C13135, C13136, C13139, C13854, C13855, C1385…

Recall date
November 29, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1010-2017
FDA classification
Class II
Brand / firm
Symmetry Surgical, Inc.
Sold / distributed
Worldwide Distribution

Why it was recalled

Sealant on the base trim of sterilizer container may be deteriorated or absent which could provide a path for contaminants to enter the container under certain conditions post-sterilization.

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

What was recalled

symmetry surgical ULTRA(R) Steam container, REF numbers: C131310, C13134, C13135, C13136, C13139, C13854, C13855, C13856, C181310, C18134, C18135, C18136, C18138, C22854, C22855, C22856, C22858, C24134, C24135, C24136 Product Usage: sterilization container

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