Class 2 Device Recall A&E Medical Thorecon Plating System Kits

• Date Initiated by Firm: September 10, 2019
• Create Date: October 30, 2019
• Recall Status: Terminated on May 12, 2020
• Recall Number: Z-0244-2020
• Recall Event ID: 83942
• 510(K)Number: K181607
• Product Classification: Cerclage, fixation - Product Code JDQ
• Product: A&E Medical Thorecon Plating System Kits Model No. 94-1400-04. For fracture fixation or reconstruction of the sternum.
• Code Information: 327705, 327706, 330587, 330588, 330753, 334396, 345417, 345418
• Recalling Firm/ Manufacturer: Alto Development Corp; 5206 Asbury Rd; Wall Township NJ 07727-3609
• For Additional Information Contact: Customer Service; 800-323-4035
• Manufacturer Reason for Recall: Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning, rendering the tensioner inoperable.
• FDA Determined Cause: Process control
• Action: On September 10, 2019, the firm distributed a letter to customers titled Product Recall: Action Required. The letter informed customers of the potential tensioner failure. Customers were given two options: 1. A&E will provide a supply of individually packaged, sterile tensioners to be kept on hand should a kit tensioner be found inoperable. Surgeons and Operating Room staff need to be alerted to this situation and the stock of additional tensioners readily available to them during surgery. 2. For those customers who prefer to return their affected lots of Thorecon, A&E will provide a Returned Goods Authorization and replacement product (to be provided as soon as inventory is available). Any failed tensioners can be discarded. Customers were asked to complete and return the acknowledgement form included with the mailing. Should you have any questions about the action or the product, please contact your A&E Sales Representative or our Customer Service at 800-323-4035.
• Quantity in Commerce: 209 total
• Distribution: Distributed to AL, CA, FL, GA, IL, LA, MO, OK, MS, NM, OK, SC, TX, UT, VT, WA, and WI.
• 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 = JDQ