Medical device recalls Moderate risk

Ethicon, Inc. recalls PDS II (Polydioxanoe) Suture Dyed & Undyed-PDSII Undyed 45cm (18") 5-0 Single Armed PS-6 Prime Needle Product Code: Z51…

Recall date
June 8, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2534-2018
FDA classification
Class II
Brand / firm
Ethicon, Inc.
Sold / distributed
Japan

Why it was recalled

Products do not meet a tensile strength specification

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

What was recalled

PDS II (Polydioxanoe) Suture Dyed & Undyed-PDSII Undyed 45cm (18") 5-0 Single Armed PS-6 Prime Needle Product Code: Z511G (GTIN 10705031061347)

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