Recall Z-1008-2025 ยท LXH Orthopedic Manual Surgical Instrument
Integrity Implants Inc.
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
| Date | Jan 22, 2025 (initiated Dec 20, 2024) |
| Status | Open, Classified |
| Reason | Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C). |
| Root 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 Track |
| Quantity | 9 |
| Distribution | U.S. Nationwide distribution in the states of CA, F, GA, KY, LA, MA, MD, TN and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.