Medtronic Sofamor Danek USA Inc

Name: Medtronic Sofamor Danek USA Inc Recall Record
Creator: PlainRecalls
License: https://creativecommons.org/publicdomain/zero/1.0/

Compiled from official public sources by the publisher. · Updated September 2026

85 recalls on record · Latest: Dec 3, 2025

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Agency notice ledger

Federal filing book Medtronic Sofamor Danek USA… MID-BOOK · SINGLE-AGENCY

#210 of 14,151 · 85 notices · 0.081% archive

BOOK 85 notices
RANK #210 of 14,151
SHARE 0.081% archive
AGENCY FDA Devices (85)
CAT medical devices
CATS 1 category
LATEST Dec 3, 2025
PHOTO Cook Incorporated

Nearest notice-volume peer: Cook Incorporated (0 notice gap)

Medtronic Sofamor Danek USA Inc accounts for about 0.081% of the 104,423-notice archive on 85 distinct filings — a heavy share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Where Medtronic Sofamor Danek USA… sits among 14,151 recalling firms

Medtronic Sofamor Danek USA Inc ranks 210th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Medtronic Sofamor Danek USA… vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

85 210th of 14151 higher than 13,941 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Beacon Hill M…

86
Carestream He…

86
Remel, Inc

86
ROi Cps LLC

86
Medtronic Sof… (this)

85
Cook Incorpor…

85

What this shows Medtronic Sofamor Danek USA Inc holds about 0.081% of archive notices alongside 85 distinct filings.

FDA Devices Moderate Dec 3, 2025

Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073 CATALYFT PL SHORT 7MM. Model Number: 6068073. 2. SPACER 6068076 CATALYFT PL LONG 7MM, Model Number: 6068076. 3. SPACER 6068093 CATALYFT PL SHORT 9MM, Model Number: 6068093. 4. SPACER 6068096 CATALYFT PL LONG 9MM, Model Number: 6068096. 5. SPACER 6068113 CATALYFT PL SHORT 11MM, Model Number: 6068113. 6. SPACER 6068116 CATALYFT PL LONG 11MM, Model Number: 6068

FDA Devices Moderate Nov 1, 2023

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

FDA Devices Moderate Nov 1, 2023

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

FDA Devices Moderate Nov 1, 2023

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

FDA Devices Moderate Nov 1, 2023

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

FDA Devices Moderate Nov 1, 2023

Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f) T43110, g) T43110INT; Demineralized Bone Matrix

FDA Devices Moderate Nov 1, 2023

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

FDA Devices Moderate Nov 1, 2023

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

FDA Devices Moderate Sep 20, 2023

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

FDA Devices Moderate Aug 16, 2023

CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K

FDA Devices Moderate Jul 19, 2023

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

FDA Devices Moderate Jul 19, 2023

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

FDA Devices Moderate Jul 19, 2023

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

FDA Devices Moderate Jul 19, 2023

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

FDA Devices Moderate Jul 19, 2023

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

FDA Devices Moderate Jul 19, 2023

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

FDA Devices Moderate Jul 19, 2023

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

FDA Devices Moderate May 17, 2023

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

FDA Devices Moderate Apr 26, 2023

INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm, REF 3604024; for immobilization and stabilization of spinal segment as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical unction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3.

FDA Devices Moderate Apr 26, 2023

INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 26mm, REF 3604026; for immobilization and stabilization of spinal segment as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical unction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3.

FDA Devices Moderate Apr 26, 2023

INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 32mm, REF 3604532; for immobilization and stabilization of spinal segment as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical unction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3.

FDA Devices Moderate Apr 26, 2023

INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 34mm, REF 3604034; for immobilization and stabilization of spinal segment as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical unction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3.

FDA Devices Moderate Apr 26, 2023

INFINITY Occipitocervical Upper Thoracic System, PARTIALLY THREADED MULTI AXIAL SCREW, Size: 4.0mm x 22mm, REF 360PT4022; for immobilization and stabilization of spinal segment as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical unction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3.

FDA Devices Moderate Apr 12, 2023

Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; b) GRAFTON T50306 DBF INJECT 6CC, REF T50306; c) GRAFTON T50309 DBF INJECT 9CC, REF T50309; Demineralized Bone Matrix (DBM) product

FDA Devices Moderate Apr 12, 2023

Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF S42200; b) DBM S42210 GRAFTON 2.5CMX5CM 2EA MATRIX, REF S42210; c) DBM T42200 2.5CMX10CM 2 EACH GRAFTON MAT, REF T42200; d) DBM T42200AUS 2.5CMX10CM 2 EA GRAFTON MX, REF T42200AUS; e) DBM T42200INT 2.5CMX10CM 2 EA GRAFTON M, REF T42200INT; f) DBM T42200JPN GRAFTON MATRIX 2.5CM X10CM, REF T42200JPN; g) DBM T42210 2.5CMX5CM 2 EACH GRAFTON MATR, REF T42210; h) DBM T42210AUS 2.5CMX5CM 2 EA GRAFTON MX, REF T42210AUS;

FDA Devices Moderate Apr 12, 2023

Medtronic Grafton Crunch a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105; b) DBM S44115 GRAFTON 15CC CRUNCH, REF S44115; c) DBM T44105 5CC GRAFTON CRUNCH, REF T44105; d) DBM T44105INT 5CC GRAFTON CRUNCH, REF T44105INT; e) DBM T44115 15CC GRAFTON CRUNCH, REF T44115; f) DBM T44115INT 15CC GRAFTON CRUNCH, REF T44115INT; Demineralized Bone Matrix (DBM) product

FDA Devices Moderate Apr 12, 2023

Medtronic XPANSE Bone Insert: a) DBM T600106 XPANSE SMALL-C 6, REF T600106; b) DBM T600206 XPANSE MEDIUM-C 6, REF T600206; c) DBM T600209 XPANSE MEDIUM-C 9, REF T600209; d) DBM T600306 XPANSE LARGE-C 6, REF T600306; e) DBM T600309 XPANSE LARGE-C 9, REF T600309; f) DBM T600612 XPANSE LARGE-L, REF T600612; Demineralized Bone Matrix (DBM) product

FDA Devices Moderate Apr 12, 2023

Medtronic Grafton Gel: a) DBM S41120 GRAFTON GEL 1CC, REF S41120; b) DBM S41150 GRAFTON GEL 10CC, REF S41150; c) DBM T41110 0.5CC GRAFTON GEL, REF T41110; d) DBM T41110INT 0.5CC GRAFTON GEL, REF T41110INT; e) DBM T41120 1CC GRAFTON GEL, REF T41120; f) DBM T41120INT 1CC GRAFTON GEL, REF T41120INT; g) DBM T41130 5CC GRAFTON GEL, REF T41130; h) DBM T41130INT 5CC GRAFTON GEL, REF T41130INT; i) DBM T41150 10CC GRAFTON GEL, REF T41150; j) DBM T41150INT 10CC GRAFTON GEL, REF T41150

FDA Devices Moderate Apr 12, 2023

Medtronic Grafton Orthoblend: a) DBM S44125 5CC ORTHOBLEND LARGE DEFECT, REF S44125; b) DBM S44135 15CC ORTHOBLEND LARGE DEFECT, REF S44135; c) DBM S44145 5CC ORTHOBLEND SMALL DEFECT, REF S44145; d) DBM S44150 10CC ORTHOBLEND SMALL DEFECT, REF S44150; e) DBM T44125 5CC ORTHOBLEND LARGE DEFGRAFT, REF T44125; f) DBM T44125AUS 5CC GRAFTON ORTHOBLEND LG, REF T44125AUS; g) DBM T44125INT 5CC GRAFTON ORTHOBLEND LG, REF T44125INT; h) DBM T44135 15CC ORTHOBLEND LARGE DEFGRAF, REF T44135; i) D

FDA Devices Moderate Apr 12, 2023

Medtronic Grafton Plus Paste a) DBM S45001 GRAFTON 1CC PASTE, REF S45001; b) DBM S45005 GRAFTON 5CC PASTE, REF S45005; c) DBM S45010 GRAFTON 10CC PASTE, REF S45010; d) DBM T45001 1CC PASTE GRAFTON PLUS, REF T45001; e) DBM T45001AUS 1CC PASTE GRAFTON PLUS, REF T45001AUS; f) DBM T45001INT 1CC PASTE GRAFTON PLUS, REF T45001INT; g) DBM T45005 5CC PASTE GRAFTON PLUS, REF T45005; h) DBM T45005INT 5CC PASTE GRAFTON PLUS, REF T45005INT; i) DBM T45010 10CC PASTE GRAFTON PLUS, REF T

FDA Devices Moderate Apr 12, 2023

Medtronic Grafton Matrix Strips: a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STRPS, REF S42275; b) DBM S42280 8MMX1CMX20CM 2EA MATRX STRPS, REF S42280; c) DBM T42275 8MMX1CMX10CM 2 EACH GRAFTON M, REF T42275; d) DBM T42275AUS 8MMX1CMX10CM 2 EA GRFTON S, REF T42275AUS; e) DBM T42275INT 8MMX1CMX10CM 2 EA GRFTON S, REF T42275INT; f) DBM T42275JPN GRAFTON MATRIX 1CM X 10CM, REF T42275JPN; g) DBM T42280 8MMX1CMX20CM 2 EACH GRAFTON M, REF T42280; h) DBM T42280AUS 8MMX1CMX20CM 2 EA GRFTON S,

FDA Devices Moderate Apr 12, 2023

Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101; b) DBM S43102 GRAFTON 1CC PUTTY, REF S43102; c) DBM S43103 GRAFTON 2.5CC PUTTY, REF S43103; d) DBM S43105 GRAFTON 5CC PUTTY, REF S43105; e) DBM S43110 GRAFTON 10CC PUTTY, REF S43110; f) DBM T43101 0.5CC GRAFTON PUTTY, REF T43101; g) DBM T43101INT 0.5CC GRAFTON PUTTY, REF T43101INT; h) DBM T43102 1CC GRAFTON PUTTY, REF T43102; i) DBM T43102INT 1CC GRAFTON PUTTY, REF T43102INT; j) DBM T43102JPN GRAF

FDA Devices Moderate Apr 12, 2023

Medtronic Grafton DBF: a) PUTTY T50101 GRAFTON DBF 1CC, REF T50101; b) PUTTY T50101INT GRAFTON DBF 1CC, REF T50101INT; c) PUTTY T50103 GRAFTON DBF 3CC, REF T50103; d) PUTTY T50103INT GRAFTON DBF 3CC, REF T50103INT; e) PUTTY T50106 GRAFTON DBF 6CC, REF T50106; f) PUTTY T50106INT GRAFTON DBF 6CC, REF T50106INT; Demineralized Bone Matrix (DBM) product

FDA Devices Moderate Apr 12, 2023

Medtronic Accelerate Grafton DBF a) ACCELERATE BG SET T50203 GRAFTON DBF 3CC, REF T50203; b) ACCELERATE BG SET T50206 GRAFTON DBF 6CC, REF T50206; c) ACCELERATE BG SET T50209 GRAFTON DBF 9CC, REF T50209; d) ACCELERATE BG SET T50212 GRAFTON DBF12CC, REF T50212; Demineralized Bone Matrix (DBM) product

FDA Devices Moderate Apr 12, 2023

Medtronic Grafton Flex: a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S42090; b) DBM T42090 1.5CMX1.5CM FLEX GRAFTON, REF T42090; c) DBM T42090INT 1.5CMX1.5CM FLEX GRAFTON, REF T42090INT; d) DBM T42100 2.5CMX10CM FLEX GRAFTON, REF T42100; e) DBM T42100AUS 2.5CMX10CM FLEX GRAFTON, REF T42100AUS; f) DBM T42100INT 2.5CMX10CM FLEX GRAFTON, REF T42100INT; g) DBM T42110 2.5CMX5CM FLEXGRAFTON, REF T42110; h) DBM T42110AUS 2.5CMX5CM FLEX GRAFTON, REF T42110AUS; i) DBM T42110INT 2.5CMX5CM FLEX

FDA Devices Moderate Oct 20, 2021

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

FDA Devices Moderate Oct 20, 2021

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

FDA Devices Moderate Jun 16, 2021

Braive Growth Modulation System Break-Off Set Screws - Product Usage: intended to limit further progression of the spinal curvature and provide correction of the thoracic curve while allowing continued skeletal growth by compression of the convex side of the scoliotic curve.

FDA Devices Moderate Apr 28, 2021

Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Large, 8 mm, Product Number 5146-1608-N - Product Usage: indicated to be used with supplemental fixation cleared by the FDA for use in the cervical spine and autograft bone, allograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof.

FDA Devices Moderate Apr 28, 2021

Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Small, 8 mm, Product Number 5146-1208-N - Product Usage: indicated to be used with supplemental fixation cleared by the FDA for use in the cervical spine and autograft bone, allograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof.

FDA Devices Moderate Jul 29, 2020

Accurian RF Ablation, Cannula pk, Accurian, 150mm, 20G, 10mm, CS Product Number: AC0012 GTIN / UPN: 20763000153629 - Product Usage: (sterile, single-use) comprises an electrically insulated shaft, an active electrode for RF energy delivery, a hub with a female slip luer fitting, and a stylet with a color-coded cap to indicate gauge size. The ACCURIAN RF Cannula included in the ACCURIAN RF Ablation Platform intended for the creation of radiofrequency lesions in nervous tissue.

FDA Devices Moderate Jul 29, 2020

Accurian RF Ablation, Cannula pk, Accurian, 100mm, 22G, 5mm, CS Product Number: AC0016 GTIN / UPN: 20763000153674 - Product Usage: (sterile, single-use) comprises an electrically insulated shaft, an active electrode for RF energy delivery, a hub with a female slip luer fitting, and a stylet with a color-coded cap to indicate gauge size. The ACCURIAN RF Cannula included in the ACCURIAN RF Ablation Platform intended for the creation of radiofrequency lesions in nervous tissue.

FDA Devices Moderate Jul 29, 2020

Accurian RF Ablation,Cannula pk, Accurian, 100mm, 22G, 10mm, SS Product Number: AC0019 GTIN / UPN: 20763000153667 - Product Usage: (sterile, single-use) comprises an electrically insulated shaft, an active electrode for RF energy delivery, a hub with a female slip luer fitting, and a stylet with a color-coded cap to indicate gauge size. The ACCURIAN RF Cannula included in the ACCURIAN RF Ablation Platform intended for the creation of radiofrequency lesions in nervous tissue.

FDA Devices Moderate Jul 29, 2020

Accurian RF Ablation, Cannula pk, Accurian, 100mm, 20G, 10mm, CS Product Number: AC0009 GTIN / UPN: 20763000153599 - Product Usage: (sterile, single-use) comprises an electrically insulated shaft, an active electrode for RF energy delivery, a hub with a female slip luer fitting, and a stylet with a color-coded cap to indicate gauge size. The ACCURIAN RF Cannula included in the ACCURIAN RF Ablation Platform intended for the creation of radiofrequency lesions in nervous tissue.

FDA Devices Moderate Jul 29, 2020

Accurian RF Ablation, Cannula pk, Accurian, 150mm, 18G, 10mm, CS Product Number: AC0007 GTIN / UPN: 20763000153568 - Product Usage: (sterile, single-use) comprises an electrically insulated shaft, an active electrode for RF energy delivery, a hub with a female slip luer fitting, and a stylet with a color-coded cap to indicate gauge size. The ACCURIAN RF Cannula included in the ACCURIAN RF Ablation Platform intended for the creation of radiofrequency lesions in nervous tissue.

FDA Devices Moderate Jul 29, 2020

Accurian RF Ablation, Cannula pk, Accurian, 100mm, 18G, 10mm, CS Product Number: AC0005 GTIN /UPN: 20763000153551 - Product Usage: (sterile, single-use) comprises an electrically insulated shaft, an active electrode for RF energy delivery, a hub with a female slip luer fitting, and a stylet with a color-coded cap to indicate gauge size. The ACCURIAN RF Cannula included in the ACCURIAN RF Ablation Platform intended for the creation of radiofrequency lesions in nervous tissue.

FDA Devices Moderate Jun 24, 2020

Medtronic Bone Void Filler, Small - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit contains the necessary components for mixing of the bone void filler.

FDA Devices Moderate Jun 24, 2020

Extremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit contains the necessary components for mixing of the bone void filler.

FDA Devices Moderate Jun 24, 2020

Medtronic Bone Void Filler, Large - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit contains the necessary components for mixing of the bone void filler.

FDA Devices Moderate May 20, 2020

VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628

Medtronic Sofamor Danek USA… carries an outsized archive share

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar recall count

Nearest multi-notice firms by distinct-event totals (85 here — heavy-book).

Cook Incorporated 85 Beacon Hill Medical Pharmacy, P.C. 86 Carestream Health, Inc. 86 Remel, Inc 86 ROi Cps LLC 86

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Cook Incorporated 85 Carestream Health, Inc. 86 Remel, Inc 86 ROi Cps LLC 86

Frequently Asked Questions

How many federal recall notices name Medtronic Sofamor Danek USA…? ▼

PlainRecalls indexes 85 distinct federal recall events naming Medtronic Sofamor Danek USA Inc, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.

Where does Medtronic Sofamor Danek USA… sit among other recalling firms? ▼

Medtronic Sofamor Danek USA Inc ranks #210 of 14,151 by distinct recall-event count among 14,151 firms in this archive (99th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.

Which agency issues most of Medtronic Sofamor Danek USA…'s notices? ▼

FDA Devices accounts for 85 of this firm's 85 indexed notices.

What product category dominates Medtronic Sofamor Danek USA…'s filing book? ▼

Filings for Medtronic Sofamor Danek USA Inc span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.

Is a higher notice count more dangerous? ▼

No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.

Medtronic Sofamor Danek USA Inc: 85 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Medtronic Sofamor Danek USA Inc; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026