FDA-Device2022-07-20Class II

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

Aesculap Implant Systems LLC
Hazard

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

Sold states
United States: TX and AK
Affected count
7 pieces
Manufactured in
3773 Corporate Pkwy, Center Valley, PA, United States
Products
AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1383-2022

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