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Medtronic Sofamor Danek Usa Inc Recalls

55 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Medtronic Sofamor Danek Usa Inc.

55Total Recalls
0Critical
383,812Units Affected
Sep 26, 2023Most Recent
All Recalls

Every Medtronic Sofamor Danek Usa Inc Recall

Sorted by most recent. Click any recall for full details.

55 recalls
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix
Medical Devices·77 affected·Sep 26, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix
Medical Devices·377 affected·Sep 26, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; Demineralized Bone Matrix
Medical Devices·430 affected·Sep 26, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix
Medical Devices·583 affected·Sep 26, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f) T43110, g) T43110INT; Demineralized ...
Medical Devices·0 affected·Sep 26, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile.
Medical Devices·55 affected·Jul 31, 2023
High RiskFDA
Medtronic Sofamor Danek Usa, Inc
CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
Medical Devices·13 affected·Jul 12, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage, REF SPS03188, spinal implant kit
Medical Implants·12 affected·Jun 6, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027722, spinal implant
Medical Implants·10 affected·Jun 6, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027725, spinal implant
Medical Implants·8 affected·Jun 6, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm, REF 3604024; for immobilization and stabilizatio...
Medical Devices·45 affected·Feb 16, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; b) GRAFTON T50306 DBF INJECT 6CC, REF T50306; c) GRA...
Medical Devices·10,037 affected·Feb 8, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF S42200; b) DBM S42210 GRAFTON 2.5CMX5CM 2EA MATRIX, REF S4...
Medical Devices·19,057 affected·Feb 8, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Grafton Crunch a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105; b) DBM S44115 GRAFTON 15CC CRUNCH, REF S44115; c) DBM T44105...
Medical Devices·5,308 affected·Feb 8, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic XPANSE Bone Insert: a) DBM T600106 XPANSE SMALL-C 6, REF T600106; b) DBM T600206 XPANSE MEDIUM-C 6, REF T600206; c) DB...
Medical Devices·4,348 affected·Feb 8, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Grafton Gel: a) DBM S41120 GRAFTON GEL 1CC, REF S41120; b) DBM S41150 GRAFTON GEL 10CC, REF S41150; c) DBM T41110 0.5C...
Medical Devices·10,090 affected·Feb 8, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Grafton Orthoblend: a) DBM S44125 5CC ORTHOBLEND LARGE DEFECT, REF S44125; b) DBM S44135 15CC ORTHOBLEND LARGE DEFECT, REF ...
Medical Devices·30,541 affected·Feb 8, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Grafton Plus Paste a) DBM S45001 GRAFTON 1CC PASTE, REF S45001; b) DBM S45005 GRAFTON 5CC PASTE, REF S45005; c) DBM S4...
Medical Devices·37,721 affected·Feb 8, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Grafton Matrix Strips: a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STRPS, REF S42275; b) DBM S42280 8MMX1CMX20CM 2EA MATRX STRPS...
Medical Devices·23,850 affected·Feb 8, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101; b) DBM S43102 GRAFTON 1CC PUTTY, REF S43102; c) DBM S431...
Medical Devices·186,889 affected·Feb 8, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in spinal surgery
Medical Devices·4 affected·Nov 19, 2021
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm
Medical Devices·9 affected·Sep 2, 2021
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm
Medical Devices·10 affected·Sep 2, 2021
High RiskFDA
Medtronic Sofamor Danek Usa, Inc
Braive Growth Modulation System Break-Off Set Screws - Product Usage: intended to limit further progression of the spinal curvature and p...
Medical Devices·162 affected·Apr 27, 2021
High RiskFDA
Medtronic Sofamor Danek Usa, Inc
Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Large, 8 mm, Product Number 5146-1608-N - Product Usag...
Medical Devices·11 affected·Mar 17, 2021
High RiskFDA
Medtronic Sofamor Danek Usa, Inc
Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Small, 8 mm, Product Number 5146-1208-N - Product Usag...
Medical Devices·11 affected·Mar 17, 2021
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Accurian RF Ablation, Cannula pk, Accurian, 150mm, 20G, 10mm, CS Product Number: AC0012 GTIN / UPN: 20763000153629 - Product Usage: (ster...
Medical Devices·352 affected·Jun 8, 2020
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Accurian RF Ablation, Cannula pk, Accurian, 100mm, 22G, 5mm, CS Product Number: AC0016 GTIN / UPN: 20763000153674 - Product Usage: (steri...
Medical Devices·5 affected·Jun 8, 2020
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Accurian RF Ablation,Cannula pk, Accurian, 100mm, 22G, 10mm, SS Product Number: AC0019 GTIN / UPN: 20763000153667 - Product Usage: (ste...
Medical Devices·25 affected·Jun 8, 2020
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Accurian RF Ablation, Cannula pk, Accurian, 100mm, 20G, 10mm, CS Product Number: AC0009 GTIN / UPN: 20763000153599 - Product Usage: (ster...
Medical Devices·2,415 affected·Jun 8, 2020
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Bone Void Filler, Small - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The...
Medical Devices·36 affected·Apr 24, 2020
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Extremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. T...
Medical Devices·41 affected·Apr 24, 2020
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Bone Void Filler, Large - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The...
Medical Devices·6 affected·Apr 24, 2020
High RiskFDA
Medtronic Sofamor Danek Usa Inc
VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628
Medical Devices·83 affected·Mar 26, 2020
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic CD HORIZON Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusio...
Medical Devices·47 affected·Jul 9, 2018
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL GUIDES: a) REF 6975205, 5mm b) REF 6975206, 6mm c) ...
Medical Implants·231 affected·Mar 13, 2018
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic ANGLED DRILL, REF 6630902, QTY: 1 EA Rx only
Medical Devices·2 affected·Dec 22, 2017
High RiskFDA
Medtronic Sofamor Danek Usa Inc
KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R.
Medical Devices·17,657 affected·May 17, 2017
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic PAK NEEDLE BEVELED AND TROCAR TIPS, REF 8670009, QTY 1 EA, STERILE R, Rx only
Medical Devices·36 affected·Apr 13, 2017
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Poly Component Trial, UCCS, packaged in the following sizes and configurations: a) Poly Comp Trial - UCCS 3x10, REF 90-SRK-170310 b) ...
Medical Devices·72 affected·Feb 20, 2017
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Poly Component Trial, CR, packaged in the following sizes and configurations: a) Poly Component Trial - CR 3x10, REF 90-SRK-160310 b)...
Medical Devices·0 affected·Feb 20, 2017
High RiskFDA
Medtronic Sofamor Danek Usa Inc
TIBIAL TRAY , SIZE 5, REF 90-SRK-200500, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement
Medical Devices·1 affected·Jul 18, 2016
High RiskFDA
Medtronic Sofamor Danek Usa Inc
TIBIAL TRAY , SIZE 2, REF 90-SRK-200200, QTY: 1, STERILE R, total knee replacement .
Medical Devices·3 affected·Jul 18, 2016
High RiskFDA
Medtronic Sofamor Danek Usa Inc
RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 5R, REF 90-SRK-311500, QTY: 1, STERILE R,
Medical Devices·0 affected·Jul 18, 2016
High RiskFDA
Medtronic Sofamor Danek Usa Inc
RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 4R, REF 90-SRK-311400, QTY: 1, STERILE R,
Medical Devices·3 affected·Jul 18, 2016
High RiskFDA
Medtronic Sofamor Danek Usa Inc
TIBIAL TRAY , SIZE 4, REF 90-SRK-200400, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement
Medical Devices·2 affected·Jul 18, 2016
High RiskFDA
Medtronic Sofamor Danek Usa Inc
KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2, REF T34A, QTY: 1EA, Rx only, STERILE R. For use with spinal fixation...
Medical Devices·239 affected·Jan 13, 2015
High RiskFDA
Medtronic Sofamor Danek Usa Inc
SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc. Screwdriver - orthopedic manual surgical inst...
Surgical Devices·7 affected·Jan 3, 2014