FDAClass IIJuly 20, 2022

Aesculap TC Cooely Micro Needlehlder Serr 200mm recall

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

Why was Aesculap TC Cooely Micro Needlehlder Serr 200mm recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI (GTIN): 04046955063277

Product
AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle
Recalling firm
Aesculap Implant Systems LLC
Quantity
7 pieces
Distribution
United States: TX and AK
Recall date
July 20, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls