Medical device recalls Moderate risk

Ethicon, Inc. recalls 1 STRATAFIX" Spiral PDS Plus Violet 36" (90cm) CTX Needle, SXPP1B402

Recall date
August 28, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1335-2020
FDA classification
Class II
Brand / firm
Ethicon, Inc.
Sold / distributed
International: Australia, Hong King, India, Japan, Korea, Singapore, Thailand

Why it was recalled

The product do not meet certain internal testing specifications.

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

What was recalled

1 STRATAFIX" Spiral PDS Plus Violet 36" (90cm) CTX Needle, SXPP1B402

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