| Class 2 Device Recall ASpace SIBD and Arcadius XP L systems | |
Date Initiated by Firm | November 10, 2015 |
Date Posted | December 16, 2015 |
Recall Status1 |
Terminated 3 on September 08, 2016 |
Recall Number | Z-0424-2016 |
Recall Event ID |
72646 |
Product Classification |
Screwdriver, surgical - Product Code LRZ
|
Product | Flexible Drill;
SJ723R; NON STERILE;
B Braun Aesculap;
Aesculap AG
These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems. |
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 | 13 |
Distribution | Worldwide Distribution: US (nationwide) and country of: Canada. |
Total Product Life Cycle | TPLC Device Report |
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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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