Class 2 Device Recall SteriSpine PS

• Date Initiated by Firm: June 03, 2022
• Create Date: August 24, 2022
• Recall Status: Completed
• Recall Number: Z-1572-2022
• Recall Event ID: 90542
• 510(K)Number: K201648
• Product Classification: Thoracolumbosacral pedicle screw system - Product Code NKB
• Product: SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.
• Code Information: KITM640: Lot numbers BF0A07 and 15BF001/R10; UDI 03760219910053; KITM645: Lot number BG0A02; UDI 03760219910060; and KITM740: Lot number BL0A01; UDI 03760219910091.
• Recalling Firm/ Manufacturer: SAFE ORTHOPAEDICS LLC; 700 W Irving Park Rd; Chicago IL 60613-1170
• Manufacturer Reason for Recall: The type of screw printed on the traceability record for the patient label is incorrect, but the type of screw printed on the other labeling is correct.
• FDA Determined Cause: Labeling Change Control
• Action: The recall letter was issued on 6/3/2022 via email to the firm's one U.S. customer. The email included a dealer recall letter, dealer response form, and a template letter for notification of any hospitals who received the product from the dealer. The letter requested the products be quarantined and the dealer should contact the hospitals who received the product to notify them of the incorrect patient labels.
• Quantity in Commerce: 8 devices
• Distribution: Distribution was made to MD. There was no government/military 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.

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