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…
Read the official notice →- Date
- 2023-07-19
- Country
- United States
- Brand
- Medtronic Sofamor Danek
- Product
- Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage, REF SPS03188, spinal implant kit
- Classification
- Class II
- Units
- US Nationwide distribution in the states of IN, WI, GA, OR, AR, OH, TN, TX,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2023-11-01
USMedtronic 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
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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
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Medtronic Sofamor Danek USA, Inc recalls CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
Incorrect Laser Marking - Solera Awl Tip Tap
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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
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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 → - 2023-04-12
- US
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.
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Other drugs & medical recalls in the United States
- 2023-07-19
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Ortho-Clinical Diagnostics recalls VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20- Used to…
Potential to cause biased results in the upper end of the reportable range for the quantitative measurement of Transferrin, C3, C4, IgA, IgG and IgM. Within the reference interval, the highest bias observed in selected…
FDA · DeviceOrtho-Clinical DiagnosticsWorldwide distribution - US Nationwide and the countries of Australia,…Official notice → - US
Abiomed, Inc. recalls Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
There was one complaint that the sidearm of the device detached during explant of a pump. When the sidearms are subjected to heat, humidity and articulation, a silicone oil contaminant that was unintentionally…
- US
GE Vingmed Ultrasound As recalls GE Healthcare Vivid S60N, ultrasound device
GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations.
- US
Abbott recalls Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).
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Baxter Healthcare Corporation recalls Allen Advance Chest Support with Pad
Potential for the device to crack where the Chest Base Prone support attaches to the carbon fiber operating room (OR) table rail.
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Osteomed, LLC recalls REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile
Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
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