Medical DeviceJan 29, 2025
N/A Repeater Bone Tamp recall — FDA Z-1008-2025
Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C).
Class IIFDA: OngoingIntegrity Implants Inc.
Recall history in this database
Classification mix: Class II: 6.
Medical DeviceDec 14, 2022
Integrity Implants LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead recall — FDA Z-0419-2023
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.
Class IIFDA: TerminatedIntegrity Implants Inc.
Medical DeviceDec 14, 2022
Integrity Implants LineSider Spinal System 5.5/6.0mm, Non-mod MIS 7.1mm - Dual Lead recall — FDA Z-0420-2023
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.
Class IIFDA: TerminatedIntegrity Implants Inc.
Medical DeviceDec 14, 2022
Integrity Implants LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm recall — FDA Z-0421-2023
Potential for intraoperative screw head separation at weld location.
Class IIFDA: TerminatedIntegrity Implants Inc.
Medical DeviceDec 14, 2022
Integrity Implants LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead recall — FDA Z-0418-2023
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.
Class IIFDA: TerminatedIntegrity Implants Inc.
Medical DeviceNov 14, 2018
Integrity Implants FlareHawk Interbody Fusion System recall — FDA Z-0405-2019
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…
Class IIFDA: TerminatedIntegrity Implants Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Integrity Implants Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.