Palm Beach Gardens, FL, United States
Integrity Implants Inc. recalls
4 recalls recorded since 2018, most recently on 20 December 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)1
Terminated or completed3
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 20 December 2024
- Reason
- Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C).
- Distribution
- U.S. Nationwide distribution in the states of CA, F, GA, KY, LA, MA, MD, TN and VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1008-2025
- 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 cor
Terminated Class II Medical devices
- Recall started
- 3 August 2022
- Terminated
- 23 October 2023
- Reason
- Potential for intraoperative screw head separation at weld location.
- Distribution
- US distribution to California, Indiana, New York, Oklahoma, Washington DC
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0421-2023
- LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Model Number LS-N6SG6545. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product
Terminated Class II Medical devices
- Recall started
- 27 January 2022
- Terminated
- 23 October 2023
- Reason
- Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from the Screw Shank.
- Distribution
- Nationwide distribution to AZ, CA, CT, DC, FL, IL, IN, LA, MA, MN, NJ, OK, PR, TN, TX, VA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0419-2023, Z-0420-2023, Z-0418-2023
- LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective s
- LineSider Spinal System 5.5/6.0mm, Non-mod MIS 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective steril
- LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protecti
Terminated Class II Medical devices
- Recall started
- 27 February 2018
- Terminated
- 6 May 2019
- Reason
- Recently Integrity Implants uncovered a discrepancy in the cleaning parameters in several of their labeling material. The firm is initiating the field correction to ensure that updated information is provided to all accounts.
- Distribution
- US nationwide in the states of AZ, CA, CO, DC, FL, GA, IA, IL, IN, KS, LA, MA, MS, NJ, NV, NY, OH, OR, PA, RI, SC, TX, and VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0405-2019
- FlareHawk Interbody Fusion System (previously XCage Interbody Fusion System) Instructions for Use (IFU's) only. Product Usage: Indicated for spinal intervertebral body fusion with autogenous bone graft in skeletally matu
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.