Every recall we track for Medtronic Sofamor Danek USA Inc — 56 in all — plus the complaints and injury reports the public filed about them.
Medtronic 6069073
Medtronic Sofamor Danek recalls specific Grafton DBM Crunch products with potential Tyvek pouch defects from improper inspection during manufacturing.
Medtronic Sofamor Danek recalls specific Grafton DBM Matrix Strips (model T42275/T42280) due to potential non-conformances in the outer Tyvek pouch from inspection errors.
Medtronic Sofamor Danek recalls specific Grafton DBM Putty models due to potential non-conformances in the outer Tyvek pouch from improper inspection during manufacturing.
Medtronic Sofamor Danek recalls specific Grafton Plus DBM Paste models (T45001, T45005, T45010) due to potential non-conformances in the outer Tyvek pouch from inspection steps.
Recall of specific Grafton DBM Orthoblend models due to potential non-conformances in the outer Tyvek pouch from inspection steps. Affected units include model numbers T44125INT, T44135, T44145, T44150 with listed serial numbers.
Medtronic Sofamor Danek recalls specific Grafton DMB Matrix products (model T42200/T42210) due to potential non-conformances in the outer Tyvek pouch during manufacturing.
Medtronic Sofamor Danek recalls specific Grafton DBM (Flex) implants due to potential non-conformances in the Tyvek pouch from improper inspection during manufacturing.
Medtronic Sofamor Danek recalls Magnifuse Bone Graft (14mm x 25mm) due to incorrect labeling indicating wrong size. Affected units have specific serial numbers and expiration date 2/15/2025.
Medtronic Sofamor Danek USA recalls Solera Awl Tip Tap (REF NAV2006K) due to incorrect laser marking. Affected units include specific batch numbers and lot numbers from the SOLERA TAPS Kit.
Medtronic recalls specific spinal implant models due to possible incorrect dimensions that could affect surgery safety. Affected units include REF 981025522 with UDI/DI 00763000465889 and lot numbers NM21J039, NM21M026.
Medtronic recalls specific spinal implants due to potential improper fit during surgery. The recall involves devices with certain model numbers and lot codes. Affected patients should contact Medtronic for guidance.
Medtronic recalls specific spinal implant models due to potential for improper device geometry affecting surgery. This could lead to inadequate spinal fusion support. Affected units include REF 981023322 with UDI/DI 00763000465865 and lot numbers NM21J001, NM21J014.
Medtronic recalls specific spinal implant models due to potential fit issues that could affect surgery outcomes. Affected units include REF 981023325 with UDI 00763000465872 and lot numbers NM21J004, NM22A032.
Medtronic recalls a specific spinal implant model due to potential improper fit during surgery, which could affect patient anatomy. Affected units have unique identifiers and lot numbers.
Medtronic recalls specific spinal implant models due to possible improper device geometry affecting surgery. Affected units may not fit patient anatomy correctly, requiring replacement.
Medtronic recalls specific spinal implant kits (REF SPS03188) due to possible incorrect device geometries that could affect spinal fusion surgery. Affected kits include lot numbers 0001-0029.
Medtronic Sofamor Danek recalls 5 batches of Infinity Occipitocervical Upper Thoracic System screws due to incorrect titanium reducing grip strength. Affected units have specific lot numbers and sizes.
Medtronic Sofamor Danek recalls Infinity Multi-Axial Screws (4.0mm x 34mm) due to reduced grip strength from incorrect titanium. Affected units have batch numbers H5806345. Contact for return or repair.
Medtronic Sofamor Danek recalls Infinity Multi-Axial Screws (4.0mm x 32mm) due to reduced grip strength from incorrect titanium. Affected units have specific batch numbers and GTIN. Contact for return or repair.
Medtronic Sofamor Danek recalls 5 batches of Infinity Multi-Axial Screws (4.0mm x 26mm) due to incorrect titanium reducing screw grip strength. Affected patients should contact for replacement.
Medtronic Sofamor Danek recalls Infinity Multi-Axial Screws (4.0mm x 24mm) due to weak grip from incorrect titanium. Affected units have batch H5802983. Contact for remedy.
Medtronic Sofamor Danek recalls specific Grafton Flex bone graft products due to potential packaging non-conformances that could breach the sterile barrier. Affected items have specific model numbers and serial numbers listed in the recall notice.
Medtronic Sofamor Danek recalls Medtronic Accelerate Grafton DBF products with specific serial numbers due to potential packaging non-conformances that could breach the sterile barrier.
Medtronic Sofamor Danek recalls specific Grafton DBF products due to potential packaging non-conformances that could breach the sterile barrier. Affected items include PUTTY T50101, T50101INT, T50103, T50103INT, T50106, T50106INT models with serial numbers listed in the recall notice.
Medtronic Sofamor Danek USA Inc recalls specific Grafton Putty products (0.5cc, 1cc, 2.5cc, 5cc, 10cc) due to potential packaging non-conformances that could breach the sterile barrier. Affected units have serial numbers listed in the recall notice.
Medtronic Sofamor Danek recalls specific Grafton Matrix Strips due to potential packaging non-conformances that could breach the sterile barrier. Affected items have unique model numbers and serials listed in the recall notice.
Medtronic Sofamor Danek USA recalls Grafton Plus Paste products with specific serial numbers due to potential packaging non-conformances that could breach the sterile barrier. Affected items may not be safe for medical use.
Medtronic Sofamor Danek recalls specific Orthoblend products with packaging defects that may breach sterile barriers. Affected items include DBM S44125, S44135, S44145, S44150, and T44125 series products with listed serial numbers and GTINs.
Medtronic Sofamor Danek recalls Grafton Gel products with specific serial numbers due to potential packaging non-conformances that could breach the sterile barrier.
Medtronic Sofamor Danek recalls XPANSE Bone Insert products with specific model numbers and serial ranges due to potential packaging non-conformances that could breach the sterile barrier.
Medtronic Sofamor Danek recalls Grafton Crunch 5CC and 15CC bone graft products due to potential packaging non-conformances that could breach the sterile barrier. Affected units have specific serial numbers and reference codes listed in the recall.
Medtronic Sofamor Danek recalls specific Grafton Matrix products due to potential packaging non-conformances that could breach the sterile barrier. Affected items have unique serial numbers listed in the recall notice.
Medtronic Sofamor Danek recalls Grafton DBF Inject 3CC and 6CC products with potential packaging non-conformances that could breach the sterile barrier. Affected items have specific serial numbers listed in the recall notice.
Medtronic Sofamor Danek recalls Distractor Rack REF 5598007 with incorrect gear width that may cause operation issues during spinal surgery. Affected units include specific lot numbers and loaner kits.
Medtronic Sofamor Danek recalls Endoskeleton TAS Interbody System with Titan nanoLOCK Surface Technology due to engraving mismatch on implant labels. Affected units have specific product numbers and lots.
Medtronic Sofamor Danek recalls Endoskeleton TCS Interbody System with Titan nanoLOCK Surface Technology due to possible mismatch between implant engraving and pouch labels. Affected units may require verification of labels before use.
Medtronic Sofamor Danek recalls Braive Growth Modulation System Break-Off Set Screws due to a thread profile defect from manufacturing. Affected models CT20L012 and CT20L020 sold until December 2028.
a ~150-character meta description summarising the recall.
a ~150-character meta description summarising the recall.
Medtronic Sofamor Danek recalls Accurian RF Cannula due to insertion difficulty caused by probe catching on cannula hub lip. Affected units have specific product numbers and lot codes. Contact for remedy details.
Medtronic recalls Accurian RF Ablation cannulas due to probe insertion difficulty caused by catching on cannula hub lip. Affected units have specific product numbers and lot codes.
Medtronic recalls Accurian RF Cannula products due to insertion difficulty caused by probe catching on cannula hub lip. Affected units have specific product numbers and lot codes.
Medtronic Sofamor Danek recalls Accurian RF Ablation Cannulas due to insertion difficulty from probe catching on cannula hub lip. Affected units have product number AC0019 and GTIN 20763000153667.
Medtronic recalls Accurian RF Ablation cannulas due to insertion difficulty caused by probe catching on cannula hub lip. Affected units have specific product number and lot code.
Medtronic Sofamor Danek recalls Accurian RF Ablation Cannula due to insertion difficulty caused by probe catching on cannula hub lip. Affected units have specific product numbers and lot numbers.
Medtronic recalls large bone void filler that may not set within labeled shelf life, potentially causing longer surgery and incomplete bone healing.
Medtronic recalls bone void filler kits that may not set correctly, causing longer surgery times and potential bone healing issues. Affected kits have product number EL153B.
Medtronic recalls small bone void filler that may not set correctly, leading to longer surgery and potential bone healing issues. Affected units have specific product numbers and lot numbers.
Medtronic Sofamor Danek recalls Vertex Select Multi Axial Screws (4.0 x 38mm) with shorter length than labeled. Affected units may not fit properly in spinal surgery.
Medtronic Sofamor Danek recalls INFUSE Bone Graft X SMALL KIT REF 7510100 with lot M111806AAA due to potential extra collagen sponges. Affected patients should contact for guidance.
Medtronic recalls CD HORIZON Spinal System screws with incorrect 5.5mm marking (actual 5.0mm) that could lead to improper spinal fusion. Affected units sold in 2023 with specific lot numbers.
Medtronic recalls a specific slot screw in spinal implants due to incorrect length. This mismatch could affect surgical stability. Affected units have a 15mm length instead of the required 17mm.
Medtronic recalls cervical disc surgery instruments with drill guides that may break during use, causing potential complications. Affected models include REF 6975205, 6975206, and 6975207 with specific lot numbers.
Medtronic recalls a single angled drill (REF 6630902) due to a longer drill tip extension than specified, which may cause improper use. Affected units have UDI 00643169363502 and lot number EM17F015.
Medtronic recalls specific size 2 directional bone filler devices due to potential misalignment of the directional arrow, which could lead to improper surgical placement. Affected units have unique lot numbers and are prescription-only.
