RecallHawk

Medtronic Sofamor Danek USA Inc

60 FDA actions

OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System

Medtronic Sofamor Danek USA, Inc.

CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal System

Medtronic Sofamor Danek USA, Inc.

CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)

Medtronic Sofamor Danek USA, Inc.

Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073

Medtronic Sofamor Danek USA Inc

CD Horizon™ Spinal System

Medtronic Sofamor Danek USA, Inc.

Infinity™ OCT System

Medtronic Sofamor Danek USA, Inc.

Endoskeleton™ Interbody Systems

Medtronic Sofamor Danek USA, Inc.

The Rialto™ SI Fusion System

Medtronic Sofamor Danek USA, Inc.

Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology

Medtronic Sofamor Danek USA, Inc.

Catalyft™ LS Expandable Interbody System

Medtronic Sofamor Danek USA, Inc.

CD Horizon™ Spinal System

Medtronic Sofamor Danek USA, Inc.

CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)

Medtronic Sofamor Danek USA, Inc.

Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix

Medtronic Sofamor Danek USA Inc

Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix

Medtronic Sofamor Danek USA Inc

Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; Demineralized Bone Matrix

Medtronic Sofamor Danek USA Inc

Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix

Medtronic Sofamor Danek USA Inc

Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f) T43110, g) T43110IN

Medtronic Sofamor Danek USA Inc

Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; Demineralized Bone Matrix

Medtronic Sofamor Danek USA Inc

Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix

Medtronic Sofamor Danek USA Inc

Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile.

Medtronic Sofamor Danek USA Inc

CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K

Medtronic Sofamor Danek USA, Inc

CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System (Modular Extended Tab Head)

Medtronic Sofamor Danek USA, Inc.

Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage, REF SPS03188, spinal implant ki

Medtronic Sofamor Danek USA Inc

Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027722, spinal implant

Medtronic Sofamor Danek USA Inc

Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027725, spinal implant

Medtronic Sofamor Danek USA Inc

Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981023325, spinal implant

Medtronic Sofamor Danek USA Inc

Medtronic Catalyft LS Expandable Interbody System, Anterier Standalone Cage, REF 981023322, spinal implant

Medtronic Sofamor Danek USA Inc

Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025525, spinal implant

Medtronic Sofamor Danek USA Inc

Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025522, spinal implant

Medtronic Sofamor Danek USA Inc

Zevo Anterior Cervical Plate System

Medtronic Sofamor Danek USA, Inc.

CD Horizon™ Spinal System

Medtronic Sofamor Danek USA, Inc.

Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in sp

Medtronic Sofamor Danek USA Inc

INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm, REF 3604024; for immobilization

Medtronic Sofamor Danek USA Inc

INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 26mm, REF 3604026; for immobilization

Medtronic Sofamor Danek USA Inc

INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 32mm, REF 3604532; for immobilization

Medtronic Sofamor Danek USA Inc

INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 34mm, REF 3604034; for immobilization

Medtronic Sofamor Danek USA Inc

INFINITY Occipitocervical Upper Thoracic System, PARTIALLY THREADED MULTI AXIAL SCREW, Size: 4.0mm x 22mm, REF 360PT402

Medtronic Sofamor Danek USA Inc

Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; b) GRAFTON T50306 DBF INJECT 6CC, REF T

Medtronic Sofamor Danek USA Inc

Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF S42200; b) DBM S42210 GRAFTON 2.5CMX5CM 2

Medtronic Sofamor Danek USA Inc

Medtronic Grafton Crunch a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105; b) DBM S44115 GRAFTON 15CC CRUNCH, REF S44115

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

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)

Medtronic Sofamor Danek USA Inc

Medtronic Grafton Orthoblend: a) DBM S44125 5CC ORTHOBLEND LARGE DEFECT, REF S44125; b) DBM S44135 15CC ORTHOBLEND L

Medtronic Sofamor Danek USA Inc

Medtronic Grafton Plus Paste a) DBM S45001 GRAFTON 1CC PASTE, REF S45001; b) DBM S45005 GRAFTON 5CC PASTE, REF S450

Medtronic Sofamor Danek USA Inc

Medtronic Grafton Matrix Strips: a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STRPS, REF S42275; b) DBM S42280 8MMX1CMX20C

Medtronic Sofamor Danek USA Inc

Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101; b) DBM S43102 GRAFTON 1CC PUTTY, REF S4310

Medtronic Sofamor Danek USA Inc

Medtronic Grafton DBF: a) PUTTY T50101 GRAFTON DBF 1CC, REF T50101; b) PUTTY T50101INT GRAFTON DBF 1CC, REF T50101

Medtronic Sofamor Danek USA Inc

Medtronic Accelerate Grafton DBF a) ACCELERATE BG SET T50203 GRAFTON DBF 3CC, REF T50203; b) ACCELERATE BG SET T50206

Medtronic Sofamor Danek USA Inc

Medtronic Grafton Flex: a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S42090; b) DBM T42090 1.5CMX1.5CM FLEX GRAFTON

Medtronic Sofamor Danek USA Inc

INFINITY OCT System

Medtronic Sofamor Danek USA, Inc.

Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology

Medtronic Sofamor Danek USA, Inc.

CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™ SPINAL SYSTEM; CD Horizon™ Fenestr

Medtronic Sofamor Danek USA, Inc.

Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth(TM) Edition

Medtronic Sofamor Danek USA, Inc.

Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments

Medtronic Sofamor Danek USA, Inc.

Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal System with Titan nanoLOCK™ Surfac

Medtronic Sofamor Danek USA, Inc.

Anteralign Spinal System with Titan nanoLOCK Surface Technology

Medtronic Sofamor Danek USA, Inc.

Catalyft LS Expandable Interbody System

Medtronic Sofamor Danek USA, Inc.

Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm

Medtronic Sofamor Danek USA Inc

Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm

Medtronic Sofamor Danek USA Inc

CD Horizon Spinal System

Medtronic Sofamor Danek USA, Inc.