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U.S. Department of Health and Human Services

Class 2 Device Recall TC COOLEY MICRO NEEDLEHOLDERS SERRATED 200MM

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  Class 2 Device Recall TC COOLEY MICRO NEEDLEHOLDERS SERRATED 200MM see related information
Date Initiated by Firm September 25, 2019
Create Date July 13, 2022
Recall Status1 Terminated 3 on April 01, 2024
Recall Number Z-1383-2022
Recall Event ID 90483
Product Classification Holder, needle; Orthopedic - Product Code HXK
Product AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle
Code Information UDI-DI (GTIN): 04046955063277
Recalling Firm/
Manufacturer		 Aesculap Implant Systems LLC
3773 Corporate Pkwy
Center Valley PA 18034-8217
For Additional Information Contact Customer Service
800-282-9000
Manufacturer Reason
for Recall		 Needleholder incorrectly labeled as 200MM when the actual instrument size is 150MM.
FDA Determined
Cause 2		 Labeling Change Control
Action 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
Quantity in Commerce 7 pieces
Distribution United States: TX and AK
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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