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…
Read the official notice →- Date
- 2024-02-07
- Country
- United States
- Brand
- XTANT Medical Holdings
- Product
- Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.
- Classification
- Class II
- Units
- US distribution in MI.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2026-04-29
USXTANT 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.
FDA · DeviceXTANT Medical Holdings, IncUS Nationwide distribution in the states and territories of CA, CT, DC, KS,…Official notice →- 2026-04-15
- US
XTANT 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
- US
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 →
Other drugs & medical recalls in the United States
- 2024-02-07
- US
Smiths Medical ASD Inc. recalls smiths medical Medfusion Model 3500 Syringe pump
Medfusion syringe pumps, with software versions before v6.0.0, may have the following issues:1. Delivery During Motor Not Running High Priority Alarm, 2. Infusion Restarted with Incorrect Parameters, 3. Screen Lock, 4.…
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
Loss of connectivity between the FlexArm and the Table due to a software issue related to the date/time format. This connection issue leads to a loss of movement of the arm or table.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide - US Nationwide distribution in the states of CO, FL, IL, MS, NV and…Official notice → - US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
Loss of connectivity between the FlexArm and the Table due to a software issue.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide - US Nationwide distribution in the states of CO, FL, IL, MS, NV and…Official notice → - US
Covidien LP recalls Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0…
Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound…
FDA · DeviceCovidien LPWorldwide US Nationwide distribution including in the states of AL, AZ, CA,…Official notice → - US
FX SHOULDER recalls Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210
Centered glenosphere box may contain an eccentric glenosphere.
- US
TERRAGENE S.A. recalls Terragene Bionova PCD (PCD222-C)
Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.
FDA · DeviceTERRAGENE S.A.U.S. Nationwide distribution in the states of GA, IN, MI, MT, NY, PA, TX and VA.Official notice →