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5 reported ongoing
5 records in this archive. Latest source date Mar 9, 2026.
FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.
Class IIReported ongoing
Distribution: US Nationwide distribution in the states and territories of CA, CT, DC, KS, MD, NC, NY, TX, and WI.
Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.
Class IIReported ongoing
Distribution: US: OR
Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, LA, OH, TX, and WV. The country of Australia.
Spinal fixation system implant screws marked "DNI" are not intended to be implanted and may not have been manufactured in accordance with released manufacturing specifications, and if implanted the screws may not have adequate strength or performance.
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of IL, WI, FL, PA, CA, TX, MI, MO, VA, OH, MA.
Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorrect screw shank component, and so the labeling is incorrect because the affected screws are in fact 5.5 diameter, 45 mm length screws, which if used may lead to...
Class IIReported ongoing
Distribution: US distribution in MI.
These examples come from this result page and are not a ranking of every recall reason.
This archive contains 5 records, including 5 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.
A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.
This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.
Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.