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U.S. Department of Health and Human Services

Class 2 Device Recall MIN0P Trocar

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  Class 2 Device Recall MIN0P Trocar see related information
Date Initiated by Firm July 20, 2023
Date Posted September 06, 2023
Recall Status1 Open3, Classified
Recall Number Z-2518-2023
Recall Event ID 92813
510(K)Number K983365  
Product Classification Endoscope, neurological - Product Code GWG
Product For intraventricular indications mainly used for operations within the brain ventricles.
Product Code: FF399R
Code Information UDI-DI: 04038653065547 Lot Numbers: 52750146 52753381, 52756472, 52768317, 52805655, 52812596, 52816570, 52823878, 52830872. Serial Numbers: 4281,4282, 4284,4288, 4289,4291, 4308,4309, 4310, 4312, 4313,4336, 4340,4341, 4342,4402, 4411, 4412, 4413,4414, 4422,4439, 4447,4449, 4450
Recalling Firm/
Manufacturer		 Aesculap Implant Systems LLC
3773 Corporate Pkwy
Center Valley PA 18034-8217
For Additional Information Contact SAME
800-258-1946
Manufacturer Reason
for Recall		 Trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a result, when used with the 30¿ neuroendoscope, a portion of the visual field is obscured.
FDA Determined
Cause 2		 Process change control
Action Aesculap issued Urgent Medical Device Recall Notification Letter via USPS Certified Mail 20.JUL.2023. Letter states reason for recall, health risk and action to take: 1. Review the Recall Notification in its entirety and ensure that all users in your organization of the above-mentioned product, and all concerned persons are informed about this voluntary product recall. 2. Your Aesculap Sales Representative will be in contact with you to review your current inventory, aid in evaluating your devices and assist you in completing the attached Product Acknowledgement Form. 3. Do not destroy any affected product. 4. Utilizing the attached form, you and your Sales Representative will record the total number of individual impacted pieces. If you have no inventory remaining, a zero (0) will be entered on the form. 5. Return the completed "Product Acknowledgement Form" to Aesculap, Inc. Product Quality Excellence department by emailing the form to PA_QualityAssurance.BBMUS_Service@bbraunusa.com or faxing the form to (610) 849-1197 after your inventory has been evaluated by your Sales Representative, even if the total inventory in your possession is zero (0). 6. Once Aesculap, Inc. receives your "Product Acknowledgement Form", a customer support representative will contact you with instructions on how to return any impacted pieces in your possession.
Quantity in Commerce 25 units
Distribution US Nationwide distribution in the states of FL, ID, IL, MD, NC, NY, OR, RI, TX.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GWG and Original Applicant = AESCULAP, INC.
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