Medical device recalls Moderate risk

Aesculap Implant Systems LLC recalls AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a su…

Recall date
September 25, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1383-2022
FDA classification
Class II
Brand / firm
Aesculap Implant Systems LLC
Sold / distributed
United States: TX and AK

Why it was recalled

Needleholder incorrectly labeled as 200MM when the actual instrument size is 150MM.

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

What was recalled

AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle

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