Integrity Implants Inc.

FDA recalling firm · 4 enforcement events · 6 product records · 2018–2024 · FL

Integrity Implants Inc. has 4 FDA enforcement events on this register (6 product records) between 2018 and 2024: 4 device; the busiest year was 2022 with 2.

0% of its events are Class I; the most common class is Class II (4). 1 event is listed as ongoing; the recalling firm's address is in FL.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
20 Dec 2024	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.…	Device	Class II	1	Ongoing
3 Aug 2022	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 sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped…	Device	Class II	1	Terminated
27 Jan 2022	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 protective sterilization trays. Screws can also be shipped individually, as tray replenishments. Labeled as…	Device	Class II	3	Terminated
27 Feb 2018	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 mature individuals with degenerative disc disease.	Device	Class II	1	Terminated

By type and class

Device4

Class II4

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Integrity Implants Inc. by year initiated.

Questions and answers

How many FDA recalls has Integrity Implants Inc. had?

4 enforcement events (6 product records) on this register, 2018–2024: 4 device.

Are any Integrity Implants Inc. recalls ongoing?

1 event is listed as ongoing in the current openFDA export.

What class are Integrity Implants Inc. recalls?

4 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.