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Medtronic Sofamor Danek USA Inc FDA Recalls
40 recalls on file across devices, 0 of them Class I and 35 still open. Matched by name to MDT.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073Class IISep 16, 2025Expandable interbody system cage may loose height or collaps |
| Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone MatrixClass IISep 26, 2023Specific serial numbers of GraftonTM DBM product due to the |
| Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; Demineralized Bone MatrixClass IISep 26, 2023Specific serial numbers of GraftonTM DBM product due to the |
| Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone MatrixClass IISep 26, 2023Specific serial numbers of GraftonTM DBM product due to the |
| Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone MatrixClass IISep 26, 2023Specific serial numbers of GraftonTM DBM product due to the |
| Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; Demineralized Bone MatrixClass IISep 26, 2023Specific serial numbers of GraftonTM DBM product due to the |
| Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f) T43110, g) T43110INClass IISep 26, 2023Specific serial numbers of GraftonTM DBM product due to the |
| Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone MatrixClass IISep 26, 2023Specific serial numbers of GraftonTM DBM product due to the |
| Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile.Class IIJul 31, 2023The incorrect product labeling was applied to the product in |
| CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006KClass IIJul 12, 2023Incorrect Laser Marking - Solera Awl Tip Tap |
| Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025522, spinal implantClass IIJun 6, 2023There is the potential for out of specification device geome |
| Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981023325, spinal implantClass IIJun 6, 2023There is the potential for out of specification device geome |
| Medtronic Catalyft LS Expandable Interbody System, Anterier Standalone Cage, REF 981023322, spinal implantClass IIJun 6, 2023There is the potential for out of specification device geome |
| Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027722, spinal implantClass IIJun 6, 2023There is the potential for out of specification device geome |
| Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025525, spinal implantClass IIJun 6, 2023There is the potential for out of specification device geome |
| Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027725, spinal implantClass IIJun 6, 2023There is the potential for out of specification device geome |
| Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage, REF SPS03188, spinal implant kiClass IIJun 6, 2023There is the potential for out of specification device geome |
| INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 26mm, REF 3604026; for immobilizationClass IIFeb 16, 2023Incorrect type of titanium was used which reduces the grippi |
| INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 32mm, REF 3604532; for immobilizationClass IIFeb 16, 2023Incorrect type of titanium was used which reduces the grippi |
| INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 34mm, REF 3604034; for immobilizationClass IIFeb 16, 2023Incorrect type of titanium was used which reduces the grippi |
| INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm, REF 3604024; for immobilizationClass IIFeb 16, 2023Incorrect type of titanium was used which reduces the grippi |
| INFINITY Occipitocervical Upper Thoracic System, PARTIALLY THREADED MULTI AXIAL SCREW, Size: 4.0mm x 22mm, REF 360PT402Class IIFeb 16, 2023Incorrect type of titanium was used which reduces the grippi |
| Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; b) GRAFTON T50306 DBF INJECT 6CC, REF TClass IIFeb 8, 2023Potential for packaging non-conformances directly related to |
| Medtronic Grafton Crunch a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105; b) DBM S44115 GRAFTON 15CC CRUNCH, REF S44115Class IIFeb 8, 2023Potential for packaging non-conformances directly related to |
| Medtronic Grafton Gel: a) DBM S41120 GRAFTON GEL 1CC, REF S41120; b) DBM S41150 GRAFTON GEL 10CC, REF S41150; c)Class IIFeb 8, 2023Potential for packaging non-conformances directly related to |
| Medtronic Grafton Matrix Strips: a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STRPS, REF S42275; b) DBM S42280 8MMX1CMX20CClass IIFeb 8, 2023Potential for packaging non-conformances directly related to |
| Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101; b) DBM S43102 GRAFTON 1CC PUTTY, REF S4310Class IIFeb 8, 2023Potential for packaging non-conformances directly related to |
| Medtronic XPANSE Bone Insert: a) DBM T600106 XPANSE SMALL-C 6, REF T600106; b) DBM T600206 XPANSE MEDIUM-C 6, REF Class IIFeb 8, 2023Potential for packaging non-conformances directly related to |
| Medtronic Grafton Flex: a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S42090; b) DBM T42090 1.5CMX1.5CM FLEX GRAFTONClass IIFeb 8, 2023Potential for packaging non-conformances directly related to |
| Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF S42200; b) DBM S42210 GRAFTON 2.5CMX5CM 2Class IIFeb 8, 2023Potential for packaging non-conformances directly related to |
| Medtronic Accelerate Grafton DBF a) ACCELERATE BG SET T50203 GRAFTON DBF 3CC, REF T50203; b) ACCELERATE BG SET T50206Class IIFeb 8, 2023Potential for packaging non-conformances directly related to |
| Medtronic Grafton DBF: a) PUTTY T50101 GRAFTON DBF 1CC, REF T50101; b) PUTTY T50101INT GRAFTON DBF 1CC, REF T50101Class IIFeb 8, 2023Potential for packaging non-conformances directly related to |
| Medtronic Grafton Plus Paste a) DBM S45001 GRAFTON 1CC PASTE, REF S45001; b) DBM S45005 GRAFTON 5CC PASTE, REF S450Class IIFeb 8, 2023Potential for packaging non-conformances directly related to |
| Medtronic Grafton Orthoblend: a) DBM S44125 5CC ORTHOBLEND LARGE DEFECT, REF S44125; b) DBM S44135 15CC ORTHOBLEND LClass IIFeb 8, 2023Potential for packaging non-conformances directly related to |
| Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in spClass IINov 19, 2021Two lots of the 5598007 Distractor Rack which were not manuf |
| Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mmClass IISep 2, 2021Engraving on implants may not match what is listed on the po |
| Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mmClass IISep 2, 2021Engraving on implants may not match what is listed on the po |
| Braive Growth Modulation System Break-Off Set Screws - Product Usage: intended to limit further progression of the spinaClass IIApr 27, 2021Product is impacted by a thread profile defect due to a manu |
| Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Large, 8 mm, Product Number 5146-1608Class IIMar 17, 2021The shelf box identifies a small device actually contains a |
| Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Small, 8 mm, Product Number 5146-1208Class IIMar 17, 2021The shelf box identifies a small device actually contains a |