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U.S. Department of Health and Human Services

Class 2 Device Recall B Braun Aesculap Tray Set

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  Class 2 Device Recall B Braun Aesculap Tray Set see related information
Date Initiated by Firm November 10, 2015
Date Posted December 16, 2015
Recall Status1 Terminated 3 on September 08, 2016
Recall Number Z-0448-2016
Recall Event ID 72646
Product Classification Tray Set - Product Code LRZ
Product Tray Set containing multiple instruments and may contain the flexible bone awl, flexible drill and/or flexible screw driver in varying amounts depending on order. Tray set is not sealed.


These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems.

Tray catalog number is: Tray designated as ST0485-037.
Code Information All Lots
Recalling Firm/
Manufacturer
Aesculap, Inc.
3773 Corporate Pkwy
Center Valley PA 18034-8217
For Additional Information Contact
800-258-1946 Ext. 5067
Manufacturer Reason
for Recall
The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a risk of a delay in surgery or that a fragment from the shaft could be left in a patient.
FDA Determined
Cause 2
Component design/selection
Action The firm, Aesculap Implant Systems, sent a "URGENT MEDICAL DEVICE RECALL" letter dated Nov. 23, 2015 to all consignees via certified letter with return receipt. Distributors and sales reps will be notified via e-mail with return receipt. The letter described the product, problem and actions to be taken. The consignees were instructed to review the product recall notification in its entirety and ensure all users your organization and other concerned persons are informed; determine your current inventory; do not destroy any affected product; immediately remove and return the affected instruments-these instruments may be located within Set ST0485; use the U joint screwdriver, ME014R in place of the SJ706R of which is already part of set ST0485; If you require Customer Service assistance please call: Customer Service: 866-229-3002 or Email: SetWorld_Orders.BBMUS_Service@aesculap.com., and complete and return the Product Removal Acknowledgement Form to Aesculap Quality Assurance Department via mail to: Aesculap Inc., 615 Lambert Pointe Drive, Hazelwood, MO 63042; fax to: 610-791-6882 or email to: val.strawn@aesculap.com within two (2) weeks of receipt, even if the total inventory in your possession is zero (0). A replacement for the SJ607R will be sent to you when one becomes available (ME190R). If you have any questions, contact via email: val.strawn@aesculap.com/Tel: 610-984-9414 or email: Gordon.young@aesculap.com/Tel: 610-984-9043.
Quantity in Commerce unknown
Distribution Worldwide Distribution: US (nationwide) and country of: Canada.
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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