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Brand Name: N/A recallZ-1008-2025 · Integrity Implants Inc. · initiated Dec 20, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Integrity Implants Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C).

FDA root cause category: Device Design

What the company is doing

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

Recall details

Recall number
Z-1008-2025
Status
Open, Classified
Initiated by the company
Dec 20, 2024
Posted by the FDA
Jan 22, 2025
Recalling firm
Integrity Implants Inc.
Quantity
9
Product code
LXH
Distribution
U.S. Nationwide distribution in the states of CA, F, GA, KY, LA, MA, MD, TN and VA.

Product description

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 (models, lots, serial numbers)

Lot Code: Part Number: ASY-00132 Lot Number: 03200045 UDI Number: (01)00810004721906(10)03200045

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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