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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