Class 2 Device Recall OrthoPediatrics ACL Reconstruction System

• Date Initiated by Firm: June 05, 2020
• Create Date: July 10, 2020
• Recall Status: Terminated on May 25, 2021
• Recall Number: Z-2539-2020
• Recall Event ID: 85837
• Product Classification: Fastener, fixation, nondegradable, soft tissue - Product Code MBI
• Product: OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number 10-1008-4070 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.
• Code Information: UDI: (01)00841132122211(17)240722(10)214320319A02 Lot#: 214320319A02
• Recalling Firm/ Manufacturer: OrthoPediatrics Corp; 2850 Frontier Dr; Warsaw IN 46582-7001
• For Additional Information Contact: Greg Teghtmeyer; 574-268-6379
• Manufacturer Reason for Recall: ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled with the incorrect size. Product labeled as 10-1008-4070 was found to have 10-1008-4060 product in the package. Product labeled as 10-1008-4060 was found to have 10-1008-4070 product in the package.
• FDA Determined Cause: Under Investigation by firm
• Action: OrthoPediatrics Corporation issued Urgent Medical Device Correction notices dated June 5, 2020 to customers via email. Customers are advised to return affected product to OrthoPediatrics Corporation. Replacement product will be provided. Please contact customer service to arrange return of the affected product. No additional corrective actions need to be taken for product already implanted. Please complete and return the attached response form confirming your understanding of these instructions. Any questions regarding this recall can be directed to Kriss Anderson, VP of Quality Systems and Regulatory Affairs, at OrthoPediatrics at kanderson@orthopediatrics.com or 574-267-0897.
• Quantity in Commerce: 11 units
• Distribution: US Nationwide distribution.
• 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.