Class 2 Device Recall OrthoPediatrics Corp

• Date Initiated by Firm: July 06, 2020
• Create Date: July 30, 2020
• Recall Status: Open, Classified
• Recall Number: Z-2742-2020
• Recall Event ID: 86027
• 510(K)Number: K150600
• Product Classification: Thoracolumbosacral pedicle screw system - Product Code NKB
• Product: Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease Model Number: 00-1300-6053
• Code Information: Lot Number: 108332-A UDI: (01)0084113212400(10)108332A
• 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: Product may have incorrect laser etched alignment lines, the non-conforming laser etch may have compromised strength, lead to unintended fracture of the device
• FDA Determined Cause: Under Investigation by firm
• Action: Orthopedics issued Field Action Notice distributed via email on July 6, 2002 stating reason for recall , heath risk and action to take: Distributors are required, to perform sub-recall. The affected product must be returned to OrthoPediatrics Corporation. Replacement product will be provided. Please contact customer service to arrange return of the affected product. Distributors should retrieve affected product that may be with customers. 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: 73 units
• Distribution: US Nationwide distribution including in the states of Al, CA, FL, GA, KY, MI, MO, NC, NY, OH, 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.

• 510(K) Database: 510(K)s with Product Code = NKB