XTANT Medical Holdings, Inc recalls nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300-251008: nanOss 3D Advanced Bone Graft…
Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.
Read the official notice →- Date
- 2026-04-29
- Country
- United States
- Brand
- XTANT Medical Holdings
- Product
- nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300-251008: nanOss 3D Advanced Bone Graft…
- Classification
- Class II
- Units
- US Nationwide distribution in the states and territories of CA, CT, DC, KS,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More XTANT Medical Holdings recalls
- 2026-04-15
USXTANT Medical Holdings, Inc recalls XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.
- 2025-02-26
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XTANT Medical Holdings, Inc recalls Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8¿, 11mm, PC (STERILE)) and Model…
Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.
FDA · DeviceXTANT Medical Holdings, IncWorldwide - US Nationwide distribution in the states of AZ, CA, CO, LA, OH,…Official notice → - 2024-10-23
- US
XTANT Medical Holdings, Inc recalls Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045
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…
FDA · DeviceXTANT Medical Holdings, IncUS Nationwide distribution in the states of IL, WI, FL, PA, CA, TX, MI, MO,…Official notice → - 2024-02-07
- US
XTANT Medical Holdings, Inc recalls Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.
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…
Other drugs & medical recalls in the United States
- 2026-04-29
- US
ARROW INTERNATIONAL, LLC recalls Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347 This device is…
Due to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured
FDA · DeviceARROW INTERNATIONAL, LLCU.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA,…Official notice → - US
Olympus Corporation of the Americas recalls OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.
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FDA · DeviceOlympus Corporation of the AmericasWorldwide distribution - US Nationwide and the countries of Canada, China,…Official notice → - US
Olympus Corporation of the Americas recalls OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
FDA · DeviceOlympus Corporation of the AmericasWorldwide distribution - US Nationwide and the countries of Canada, China,…Official notice → - US
Davol, Inc. recalls Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.
Potential for product to contain foreign matter, confirmed to be inspect fragments.
FDA · DeviceDavol, Inc.Worldwide distribution - US Nationwide and the countries of China, South Korea.Official notice → - US
Magellan Diagnostics, Inc. recalls LeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare¿ Plus kit is provided with the following materials: "…
Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results…
FDA · DeviceMagellan Diagnostics, Inc.Worldwide - US Nationwide and the countries of Argentina, Australia, Bhutan,…Official notice → - US
Medline Industries, LP recalls Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes GU DAVINCI PACK - LF DYNJ909398A ROBOTIC PACK…
Unapproved design changes to the products outside of the 510(k) clearance.
FDA · DeviceMedline Industries, LPWorldwide distribution - US Nationwide and the countries of Canada, Panama,…Official notice →