Class 2 Device Recall Caspar Cervical Retractor (CCR) Basket

• Date Initiated by Firm: February 23, 2023
• Date Posted: April 25, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1430-2023
• Recall Event ID: 91968
• Product Classification: Tray, surgical, instrument - Product Code FSM
• Product: Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical Retractor (CCR) Basket Full System - Lid Only. A lid to a container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments. Note: The CCR basket lid is also distributed with ME764 CCR Basket - Full System
• Code Information: GUIDID: 04046955299592 (Basket Lid)
• 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: Mislabeled: Product is marked with GTIN # 04046955299592 however; the correct GTIN # is 04046955299607.
• FDA Determined Cause: Employee error
• Action: Aesculap Implant Systems, LLC, issued Urgent Medical Device Recall Notification letter on 2/23/23. Letter states reason for recall, health risk and action to take: 1. Review the Device Recall Notification in its entirety and ensure that all users in your organization of the above-mentioned product, and other concerned persons, are informed about this voluntary product recall. If you are a distributor, please forward this recall notification to your customers. The recall is to be extended to the end user/customer level. 2. Determine your current inventory of the affected lots within your facility. cease use and guarantine product subject to recall. Do not destroy any affected product. 3. Utilizing the attached "Product Recall Acknowledgement Form," record the total number of individual units in your possession. If you have no inventory remaining, please enter zero (0) on the form. 4. Return the completed "Product Recall Acknowledgment Form" form to B. Braun Medical Inc. Quality Assurance department by faxing the form to (610) 849-1197 or e-mail to PA QualityAssurance.BBMUS Service@bbraunusa.com within two (2) weeks of receipt, even if the total inventory in your possession is zero (0). 5. Once we receive your Acknowledgement Form, a B. Braun Customer Support representative will contact you to arrange for shipment of a replacement lid and to have your current inventory returned.
• Quantity in Commerce: ME754: 3 units; ME764: 22 units
• Distribution: US Nationwide distribution in the states of CA, OH, NE, NH, FL, PA, 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.