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INTEGRITY IMPLANTS INC. — FDA Facility Profile

FEI 3012797630

INTEGRITY IMPLANTS INC. is an FDA-registered facility (FEI 3012797630) located in Palm Bch Gdns, FL, US. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection
May 30, 2019: Voluntary Action Indicated (VAI)
Inspections on record
1 (1 VAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Recalls as the recalling firm
4, latest Dec 20, 2024

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
May 30, 2019Voluntary Action Indicated (VAI)Lack of or inadequate complaint procedures (21 CFR 820.198(a))
Purchasing controls, Lack of or inadequate procedures (21 CFR 820.50)

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Dec 20, 2024Not yet classifiedZ-1008-2025Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number…
Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C).
Aug 3, 2022Not yet classifiedZ-0421-2023LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead…
Potential for intraoperative screw head separation at weld location.
Jan 27, 2022Not yet classifiedZ-0418-2023LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated… and 2 more products
Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of…
Feb 27, 2018Not yet classifiedZ-0405-2019FlareHawk Interbody Fusion System (previously XCage Interbody Fusion System) Instructions…
Recently Integrity Implants uncovered a discrepancy in the cleaning parameters in several of their labeling material. The firm is initiating…

Facility details

Company
Integrity Implants Inc.
Location
Palm Bch Gdns, FL (US)
Source
device

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.