Medtronic Sofamor Danek USA Inc recalls Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a…
Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related to the presence of microbial organisms. While the batch…
Read the official notice →- Date
- 2026-10-21
- Country
- United States
- Brand
- Medtronic Sofamor Danek
- Product
- Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone…
- Classification
- Class II
- Units
- US Nationwide distribution in the states of OK, VA, CO, AR, FL, TX, MD, DE,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Medtronic Sofamor Danek recalls
- 2025-12-03
Medtronic Sofamor Danek USA Inc recalls Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073 CATALYFT…
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FDA · DeviceMedtronic Sofamor Danek USA IncWorldwide distribution - US Nationwide and Puerto Rico. The countries of…Official notice →- 2023-11-01
Medtronic Sofamor Danek USA Inc recalls Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix
Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have…
FDA · DeviceMedtronic Sofamor Danek USA IncUS, Colombia, S. Korea, New Zealand, India, TaiwanOfficial notice →- 2023-09-20
Medtronic Sofamor Danek USA Inc recalls Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile.
The incorrect product labeling was applied to the product indicating the wrong size of product.
FDA · DeviceMedtronic Sofamor Danek USA IncUS Nationwide distribution in the states of ID, IN, MN, NC, NY, OH, OR, WA,…Official notice →- 2023-08-16
Medtronic Sofamor Danek USA, Inc recalls CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
Incorrect Laser Marking - Solera Awl Tip Tap
FDA · DeviceMedtronic Sofamor Danek USA, IncUS Nationwide distribution in the states of FL, CO, IN, SC, TX, UT.Official notice →- 2023-07-19
Medtronic Sofamor Danek USA Inc recalls Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage, REF SPS03188, spinal implant kit
There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral…
FDA · DeviceMedtronic Sofamor Danek USA IncUS Nationwide distribution in the states of IN, WI, GA, OR, AR, OH, TN, TX,…Official notice →- 2023-05-17
Medtronic Sofamor Danek USA Inc recalls Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in spinal…
Two lots of the 5598007 Distractor Rack which were not manufactured to specification. The crest width of the gear is too wide and may cause difficulty or the inability to operate the Distractor.
Other drugs & medical recalls in the United States
- 2026-10-21
Neuronetics, Inc. recalls NeuroStar Advanced Therapy System. Contains the NeuroStar HP Coil Assembly Part Number 81-01000-200. Affects the below NeuroStar Advanced…
Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly.
FDA · DeviceNeuronetics, Inc.Worldwide distribution - US Nationwide and the countries of Japan and South…Official notice →Cadwell Industries Inc recalls Brand Name: IOMAX Product Name: IOMAX Cortical Module Model/Catalog Number: 190296-200 UDI-DI code: 00840067100653 Product Description:…
Stimulator device contains a defective printed circuit board assembly (PCBA) that may cause the device to unintentionally deliver electrical stimulation to the patient, or allow an unintended electrical current to…
FDA · DeviceCadwell Industries IncWorldwide - US Nationwide distribution in the state of TN and the countries of…Official notice →Becton Dickinson & Co. recalls BD Phoenix Panel NMIC-312. Catalog Number: 449082.
Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature.
Jenavalve Technology Inc. recalls JenaValve Trilogy Delivery Catheter, Size 27MM REF: TRILOGY-DC-L
Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.
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FDA · DeviceInstrumentation LaboratoryWorldwide - US Nationwide distribution in the states of AR, AZ, CA, CT, FL,…Official notice →