Medtronic Sofamor Danek recalls
9 official recalls and safety alerts involving Medtronic Sofamor Danek since 2021-10, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Medtronic Sofamor Danek or the relevant agency.
- 2025-12-03
USMedtronic Sofamor Danek USA Inc recalls Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073 CATALYFT…
Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be…
FDA · DeviceMedtronic Sofamor Danek USA IncWorldwide distribution - US Nationwide and Puerto Rico. The countries of…Official notice →- 2023-11-01
- US
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
- 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 → - 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.
FDA · DeviceMedtronic Sofamor Danek USA IncWorldwide distribution - US Nationwide and the countries of Australia,…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 →