Class 2 Device Recall Response 5.5/6.0 Spine System

• Date Initiated by Firm: November 10, 2015
• Create Date: January 08, 2016
• Recall Status: Terminated on May 23, 2016
• Recall Number: Z-0622-2016
• Recall Event ID: 72962
• 510(K)Number: K150600
• Product Classification: Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
• Product: UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw; ; 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 (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
• Code Information: Item number; lot; product description 00-1300-1735; 44003; 5.5/6.0 UNIAXIAL REDUCTION PEDICLE SCREW 7.0MM X 35MM. 00-1300-0735; 44601; 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 35MM. 00-1300-0740; 44602; 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 40MM. 00-1300-0740; 43926; 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 40MM. 00-1300-0740; 44252; 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 40MM. 00-1300-0745; 43927; 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 45MM. 00-1300-0750; 44619; 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 50MM. 00-1300-0620; 44623; 5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 20MM. 00-1300-0640; 44617; 5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 40MM. 00-1300-0640; 44884; 5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 40MM. 00-1300-1745; 44005; 5.5/6.0 UNIAXIAL REDUCTION PEDICLE SCREW 7.0MM X 45MM. 00-1300-0635; 44677; 5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 35MM.
• 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: Response Spine UniAxial Pedicle & UniAxial Reduction Pedicle Screws may have been manufactured incorrectly, thus preventing the driver from fully engaging into the hexagonal drive feature of the screw.
• FDA Determined Cause: Process change control
• Action: The firm, OrthoPediatrics Corp., sent an "URGENT MEDICAL DEVICE RECALL" letter dated 11/13/2015 to affected customers via email. The letter included a description of the reason for the recall, affected product, consignee responsibilities, and actions to be taken. The customers were instructed to take immediate possession of all the identified devices; quarantine them and immediately return them to OrthoPediatrics, and complete and return the Mandatory Reply Form via fax to (574) 269-3692 or email: MF0x@OrthoPediatrics.com. If you have any questions, please contact VP-Regulatory Affairs (574) 268-6379 or email: mfox@orthopediatrics.com.
• Quantity in Commerce: 102
• Distribution: US Distribution to states of: AL, AZ, CA, DE, FL, GA, HI, KY, LA, MI, MO, MN, MS, NC, NJ, NY, OH, OR, TN, and 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 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 = NKB and Original Applicant = ORTHOPEDIATRICS CORP.