Medical device recalls Moderate risk

Symmetry Surgical, Inc. recalls symmetry surgical ULTRA(R) Gravity container, REF numbers: C131310-G, C13134-G, C13135-G, C13136-G, C13139-G, C13854-G,…

Recall date
November 29, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1012-2017
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) Gravity container, REF numbers: C131310-G, C13134-G, C13135-G, C13136-G, C13139-G, C13854-G, C13855-G, C13856-G, C181310-G, C18134-G, C18135-G, C18136-G, C18138-G, C22854-G, C22855-G, C22856-G, C22858-G, C24134-G, C24135-G, C24136-G, C24138, C24138-G Product Usage: sterilization container

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