Medical device recalls Moderate risk

Aesculap Implant Systems LLC recalls CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM REF: PL730SU - Product Usage: Instrument intended for use in general surgery and…

Recall date
August 7, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2496-2019
FDA classification
Class II
Brand / firm
Aesculap Implant Systems LLC
Sold / distributed
US Nationwide distribution in the state of CA.

Why it was recalled

possibility of the sterility batch being insufficiently sterilized

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

What was recalled

CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM REF: PL730SU - Product Usage: Instrument intended for use in general surgery and gynecologic procedures where ligation and division of vessels is desired.

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