Class 2 Device Recall 3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm

• Date Initiated by Firm: January 08, 2014
• Date Posted: February 06, 2014
• Recall Status: Terminated on April 23, 2014
• Recall Number: Z-0934-2014
• Recall Event ID: 67302
• Product Classification: Screw, fixation, bone - Product Code HWC
• Product: 3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm; Part No. 00-0903-2620; ; OrthoPediatrics Pediloc" Tibia Plates are indicated for fractures, osteotomies, and non-unions of the pediatric and small stature adult tibia. The subject recalled device is a Bone Screw designed for use with this system.
• Code Information: Lot 009SV
• 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: OrthoPediatrics has initiated a Voluntary RECALL of Part # 00-0903-2620, 3.5MM Locking Cortical Screw, Lot # 009SV because the device within the package may be incorrect. These packages incorrectly contain a 3.5mm Non Locking Cortical Screw # 00-1050-3524.
• FDA Determined Cause: Labeling mix-ups
• Action: Orthopediatrics Corporation has requested sales representatives and distributors who have been identified via shipping records as having the possibility of having received one or more discrepant devices affected by this Recall were requested to quarantine the devices identified in this Recall by telephone on January 8, 2014. The decision to Recall these devices was made and a formal written Recall Notice sent to the consignees via email on January 13, 2014. Notification will not be sent to hospitals at this time provided that all devices are retrieved or accounted for within 60 days of the initiation of recall. Hospitals will be notified on an as needed basis if OrthoPediatrics determines that all recalled devices have not been recovered or accounted for, and that contacting the hospitals involved will expedite the recall efforts. All discrepant devices subject to this voluntary Recall are planned to be returned from distribution to OrthoPediatrics Corp. in Warsaw, Indiana and maintained in quarantine. All remaining unshipped devices from these lots have been placed in quarantine at OrthoPediatrics Corp. All quarantined devices at OrthoPediatrics will be inspected and repackaged to correct the mislabeling per normal documented procedures. Objective evidence will be maintained of the rework of the devices. For questions regarding this recall call 574-268-6379.
• Quantity in Commerce: 12 units
• Distribution: Worldwide Distribution - USA including OK, KY, FL, LA, OH, CO, MO, MN and Internationally to Ireland, Saudi Arabia, Italy, Turkey, South Africa, and Germany.
• 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.