Z-1008-2025Class II

Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-00132 Software Version: N/A...

Name: Z-1008-2025 Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-00132 Software Version: N/A...
Creator: Integrity Implants Inc.
Published: 2024-12-20
License: https://open.fda.gov/license/

Integrity Implants, Inc. / initiated 2024-12-20 / Open, Classified / root cause: design

FDA source

Integrity Implants Inc. began a recall of 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... on 2024-12-20. FDA classified it as Class II and gives the reason as "Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1008-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-12-20
Posted: 2025-01-22
Recalling firm: Integrity Implants, Inc.
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
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C).
Root cause tag: design
FDA 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 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.
Product codes and lots: Lot Code: Part Number: ASY-00132 Lot Number: 03200045 UDI Number: (01)00810004721906(10)03200045

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1008-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1008-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-29	2025-01-22

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)