Medtronic Sofamor Danek USA Inc recalls Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; b) GRAFTON T50306 DBF INJECT 6CC, REF T50306; c)…
Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.
Read the official notice →- Date
- 2023-04-12
- Country
- United States
- Brand
- Medtronic Sofamor Danek
- Product
- Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; b) GRAFTON T50306 DBF INJECT 6CC, REF T50306; c) GRAFTON…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of Australia,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2023-09-20
US
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
US
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
US
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
US
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.
- 2023-04-26
US
Medtronic Sofamor Danek USA Inc recalls INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm, REF 3604024; for immobilization and…
Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
FDA · DeviceMedtronic Sofamor Danek USA IncWorldwide distribution - US Nationwide and the country of Canada.Official notice →- 2021-10-20
US
Medtronic Sofamor Danek USA Inc recalls Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm
Engraving on implants may not match what is listed on the pouch labels.
FDA · DeviceMedtronic Sofamor Danek USA IncDistribution in US: CA, MN, MO, NC, NV, NY, OH, OK, OR, PA, SC, SD, WA, WVOfficial notice →
Other drugs & medical recalls in the United States
- 2023-04-12
US
Stryker Corporation recalls Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PRT QUICK Catalog number: 5921-030-135NS Indicated for use…
Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood…
US
Moberg Research, Inc. recalls Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-term neurological monitoring system that collects, displays, and…
Battery leakage can cause corrosion to the metal enclosure near the electrical interface. Prolonged contact to corrosive materials could cause injury to skin. DOC
FDA · DeviceMoberg Research, Inc.Worldwide distribution - US Nationwide and the countries of France, Germany,…Official notice →US
Maquet Cardiovascular, LLC recalls VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000
Some batches of product were not sterilized to their minimum sterilization specification.
FDA · DeviceMaquet Cardiovascular, LLCWorldwide distribution - US Nationwide and the countries of Brazil, China.Official notice →US
Philips Respironics, Inc. recalls Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, UDSX500S11F, UDSX700S11, UDSX700S11F, UFRX500S14.…
A limited number of remediated Philips DreamStation units may experience communication issues when connecting to the cloud-based care management application. Should this be the case, this may affect the ability to…
US
Remote Diagnostic Technologies Ltd. recalls Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified…
During internal testing, Regulatory Compliance issues were identified regarding the Monitor and Power Supplies for fluid ingress and basic safety issues.
FDA · DeviceRemote Diagnostic Technologies Ltd.Worldwide Distribution: U.S.(nationwide): AL, AZ, CA, CO, DC, DE, FL, GA, HI,…Official notice →US
Biosense Webster, Inc. recalls Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile
Incorrect labeling; specifically, the product name, lot number and product code on the carton label for Bi-Directional Guiding Sheaths does not match the inner label pouch
FDA · DeviceBiosense Webster, Inc.Worldwide distribution - US Nationwide distribution including the states of…Official notice →