Class 2 Device Recall Orthex

• Date Initiated by Firm: June 29, 2022
• Create Date: September 06, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1678-2022
• Recall Event ID: 90738
• 510(K)Number: K151881
• Product Classification: Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
• Product: Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
• Code Information: UDI: 00841132179468 Lot Numbers: 239006-B and 238997-B
• Recalling Firm/ Manufacturer: OrthoPediatrics Corp; 2850 Frontier Dr; Warsaw IN 46582-7001
• For Additional Information Contact: Mallory Trusty; 574-268-6379
• Manufacturer Reason for Recall: Manufacturing variance near transition of tip is increasing the likelihood the wire tip may fracture. The fractured tip may be retained in the patient. Retrieval attempts may be made which could result in a delay of surgery and potentially damage soft tissue and increase healing time
• FDA Determined Cause: Process change control
• Action: OrthoPediatrics Corp. provided Urgent Medical Device recall Letter to Distributors on 6/29/22. Letter states reason for recall, health risk and action to take: 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 acknowledgement form confirming your understanding of these instructions. Any questions regarding this recall can be directed to Joel Batts, Senior VP of Science & Technology, at OrthoPediatrics at jbatts@orthopediatrics.com or 574-367-5396.
• Quantity in Commerce: 640 units
• Distribution: US Nationwide Distribution: AZ, AL, CA, FL, FL, MD, MO, NC, NY, TX Foreign: Australia
• 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 = KTT