Home / Recalls / Integrity Implants Inc. / Z-1008-2025

Z-1008-2025 Class II Ongoing

Recalled by Integrity Implants Inc. — Palm Beach Gardens, FL

Recall Details

Product Type
Devices
Report Date
January 29, 2025
Initiation Date
December 20, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9

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

Reason for Recall

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

Distribution Pattern

U.S. Nationwide distribution in the states of CA, F, GA, KY, LA, MA, MD, TN and VA.

Code Information

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

Other recalls by Integrity Implants Inc.

  • Z-0421-2023 Class II — LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual (August 3, 2022)
  • Z-0418-2023 Class II — LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannu (January 27, 2022)
  • Z-0419-2023 Class II — LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannulate (January 27, 2022)
  • Z-0420-2023 Class II — LineSider Spinal System 5.5/6.0mm, Non-mod MIS 7.1mm - Dual Lead, Cannulated. T (January 27, 2022)
  • Z-0405-2019 Class II — FlareHawk Interbody Fusion System (previously XCage Interbody Fusion System) Ins (February 27, 2018)