Medical device recalls Moderate risk

Incisive Surgical Inc recalls INSORB SUBCUTICULAR SKIN STAPLER, REF 2030

Recall date
August 29, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0078-2019
FDA classification
Class II
Brand / firm
Incisive Surgical Inc
Sold / distributed
Israel

Why it was recalled

Possible compromise of the sterile barrier integrity

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

What was recalled

INSORB SUBCUTICULAR SKIN STAPLER, REF 2030

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