RecallDepth

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

Company
Aesculap Implant Systems Llc
Recall Initiated
September 25, 2019
Terminated
April 1, 2024
Recall Number
Z-1383-2022
Quantity
7 pieces
Firm Location
Center Valley, PA

Reason for Recall

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

Distribution

United States: TX and AK

Lot / Code Info

UDI-DI (GTIN): 04046955063277

Root Cause

Labeling Change Control

Action Taken

Field Action Notification letter was issued September 25, 2019 via letter sent USPS certified mail with return receipt. Customers are to review inventory, return affected product and the acknowledgement form. For questions contact (800) 282-9000 or via email at: emailorders@aesculapusa.com

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