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U.S. Department of Health and Human Services

Class 2 Device Recall S4C CROSS CONNECTOR

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  Class 2 Device Recall S4C CROSS CONNECTOR see related information
Date Initiated by Firm September 08, 2020
Create Date July 21, 2022
Recall Status1 Terminated 3 on April 10, 2024
Recall Number Z-1445-2022
Recall Event ID 90502
510(K)Number K062012  
Product Classification Thoracolumbosacral pedicle screw system - Product Code NKB
Product AESCULAP S4 Cervical Cross Connector, L26mm, S4C CROSS CONNECTOR FIXED 26MM, product code SW114T. Used in spinal fusion surgery.
Code Information UDI-DI: 04038653362318
Recalling Firm/
Manufacturer		 Aesculap Implant Systems LLC
3773 Corporate Pkwy
Center Valley PA 18034-8217
For Additional Information Contact Lindsay Chromiak
610-984-9072
Manufacturer Reason
for Recall		 Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.
FDA Determined
Cause 2		 Device Design
Action An Urgent Medical Device Removal Notification issued September 08, 2020 sent via USPS certified mail. The notice identifies the affected part numbers S4C CROSS CONNECTOR SW112T, SW113T, SW114T, SW115T, SW116T and SW117T and asks distributors and customers to identify existing inventory, quarantine, and return affected inventory. If further distributed, identify and notify customers. The notice includes an acknowledgement form to be completed and returned to Aesculap Inc. via email at qa-recalls@aesculapusa.com. Questions are to be directed to Lindsay Chromiak, Manager, QA Compliance and Vigilance (610) 984-9072.
Quantity in Commerce 24
Distribution United States Nationwide distribution in the states of CA, CO, IL, IN, MI, NC, NV, OH, PA, SC, TX & WY.
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.
510(K) Database 510(K)s with Product Code = NKB and Original Applicant = AESCULAP, INC.
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