Class 2 Device Recall Repeater Bone Tamp

• Date Initiated by Firm: December 20, 2024
• Date Posted: January 22, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1008-2025
• Recall Event ID: 96099
• Product Classification: Orthopedic manual surgical instrument - Product Code LXH
• Product: Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-00132 Software Version: N/A Product Description: The Repeater Bone Tamp is a cylindrical shaft used to push bone graft material through a corresponding bone funnel into the FlareHawk interbody fusion device in spinal fusion procedures. Component: No
• Code Information: Lot Code: Part Number: ASY-00132 Lot Number: 03200045 UDI Number: (01)00810004721906(10)03200045
• FEI Number: 3012797630
• Recalling Firm/ Manufacturer: Integrity Implants Inc.; 354 Hiatt Dr; Palm Beach Gardens FL 33418-7236
• For Additional Information Contact: Chris McKee; 1-561-5293861
• Manufacturer Reason for Recall: Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C).
• FDA Determined Cause: Device Design
• Action: On 12/20/2024, the firm emailed a "NOTICE OF RECALL" letter to customer informing them that the firm has received a report relating to a specific lot of Repeater Bone Tamps not fitting with newer lots of the Repeater Bone Funnel. Customers are instructed to: 1. Segregate Product. immediately remove all Repeater Bone Tamp (Part # ASY-00132, Lot Number 03200045), from their inventory (regardless of its location) and segregate this product in a secure location for return to Accelus. 2. Complete QF-00070 Product Tracking & Verification Form. Complete and return the enclosed QF-00070 Product Tracking & Verification Form (even if you do not have any product to return), following the directions on this page and QF-00070 Product Tracking & Verification Form. Accelus' customer service representative can assist in completing the form. 3. Indicate Returned Products on QF-00070 Product Tracking & Verification Form. QF-00070 Product Tracking & Verification Form lists the Repeater Bone Tamp and product descriptions. Mark the number of each type of Repeater Bone Tamp that will be returned on this form. 4. Call (561)529-3861 or 1-800-201-9300 from 8:30am to 5pm (EDT) should there be any questions about returning the product. Customer's Accelus account will be credited in an amount equal to the actual purchase price for the returned product, if applicable. Inform Customer Service Representative whether customers would like to order a replacement product. 5. Package the Return Material. Package Repeater Bone Tamp(s) that are being returned in an appropriate shipping box. Place a signed original copy of QF-00070 Product Tracking & Verification Form in the box, appropriately seal the box and send it on or before 12-26-2024, to: Accelus 354 Hiatt Drive, Suite 100 Palm Beach Gardens, FL 33418 Office: (561)529-3861 or 1-800-201-9300 Fax: (561) 529-3869
• Quantity in Commerce: 9
• Distribution: U.S. Nationwide distribution in the states of CA, F, GA, KY, LA, MA, MD, TN and VA.
• 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.