Medtronic Sofamor Danek Usa Inc
Memphis, TN
This page shows every FDA and USDA recall linked to Medtronic Sofamor Danek Usa Inc. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
172
Total Recalls
2006
First Recall
2025
Most Recent
Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers:
1. SPACER...
Nov 21, 2025
· Device
Open, Classified
Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix
Oct 25, 2023
· Device
Open, Classified
Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix
Oct 25, 2023
· Device
Open, Classified
Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix
Oct 25, 2023
· Device
Open, Classified
Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; Demineralized Bone Matri...
Oct 25, 2023
· Device
Open, Classified
Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f) T43110, g...
Oct 25, 2023
· Device
Open, Classified
Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix
Oct 25, 2023
· Device
Open, Classified
Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; Demineralized Bone Matrix
Oct 25, 2023
· Device
Open, Classified
Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile.
Sep 8, 2023
· Device
Open, Classified
CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
Aug 9, 2023
· Device
Open, Classified
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025525, spinal implant
Jul 10, 2023
· Device
Open, Classified
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025522, spinal implant
Jul 10, 2023
· Device
Open, Classified
Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage, REF SPS03188, spinal...
Jul 10, 2023
· Device
Open, Classified
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027722, spinal implant
Jul 10, 2023
· Device
Open, Classified
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027725, spinal implant
Jul 10, 2023
· Device
Open, Classified
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981023325, spinal implant
Jul 10, 2023
· Device
Open, Classified
Medtronic Catalyft LS Expandable Interbody System, Anterier Standalone Cage, REF 981023322, spinal implant
Jul 10, 2023
· Device
Open, Classified
Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for...
May 10, 2023
· Device
Open, Classified
INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm, REF 3604024; for immo...
Apr 19, 2023
· Device
Open, Classified
INFINITY Occipitocervical Upper Thoracic System, PARTIALLY THREADED MULTI AXIAL SCREW, Size: 4.0mm x 22mm, RE...
Apr 19, 2023
· Device
Open, Classified
INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 34mm, REF 3604034; for immo...
Apr 19, 2023
· Device
Open, Classified
INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 32mm, REF 3604532; for immo...
Apr 19, 2023
· Device
Open, Classified
INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 26mm, REF 3604026; for immo...
Apr 19, 2023
· Device
Open, Classified
Medtronic Grafton DBF Inject:
a) GRAFTON T50303 DBF INJECT 3CC, REF T50303;
b) GRAFTON T50306 DBF INJECT 6C...
Apr 4, 2023
· Device
Open, Classified
Medtronic Grafton Matrix:
a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF S42200;
b) DBM S42210 GRAFTON 2.5...
Apr 4, 2023
· Device
Open, Classified
Medtronic Grafton Plus Paste
a) DBM S45001 GRAFTON 1CC PASTE, REF S45001;
b) DBM S45005 GRAFTON 5CC PASTE,...
Apr 4, 2023
· Device
Open, Classified
Medtronic Grafton DBF:
a) PUTTY T50101 GRAFTON DBF 1CC, REF T50101;
b) PUTTY T50101INT GRAFTON DBF 1CC, RE...
Apr 4, 2023
· Device
Open, Classified
Medtronic Grafton Flex:
a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S42090;
b) DBM T42090 1.5CMX1.5CM FLEX...
Apr 4, 2023
· Device
Open, Classified
Medtronic Grafton Putty:
a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101;
b) DBM S43102 GRAFTON 1CC PUTTY, R...
Apr 4, 2023
· Device
Open, Classified
Medtronic Accelerate Grafton DBF
a) ACCELERATE BG SET T50203 GRAFTON DBF 3CC, REF T50203;
b) ACCELERATE BG SE...
Apr 4, 2023
· Device
Open, Classified
Medtronic Grafton Gel:
a) DBM S41120 GRAFTON GEL 1CC, REF S41120;
b) DBM S41150 GRAFTON GEL 10CC, REF S41150...
Apr 4, 2023
· Device
Open, Classified
Medtronic Grafton Crunch
a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105;
b) DBM S44115 GRAFTON 15CC CRUNCH, RE...
Apr 4, 2023
· Device
Open, Classified
Medtronic Grafton Orthoblend:
a) DBM S44125 5CC ORTHOBLEND LARGE DEFECT, REF S44125;
b) DBM S44135 15CC ORTH...
Apr 4, 2023
· Device
Open, Classified
Medtronic Grafton Matrix Strips:
a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STRPS, REF S42275;
b) DBM S42280 8MM...
Apr 4, 2023
· Device
Open, Classified
Medtronic XPANSE Bone Insert:
a) DBM T600106 XPANSE SMALL-C 6, REF T600106;
b) DBM T600206 XPANSE MEDIUM-C...
Apr 4, 2023
· Device
Open, Classified
Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium...
Sep 2, 2021
· Device
Terminated
Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 1...
Sep 2, 2021
· Device
Terminated
Braive Growth Modulation System Break-Off Set Screws - Product Usage: intended to limit further progression of...
Apr 27, 2021
· Device
Terminated
Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Large, 8 mm, Product Number...
Mar 17, 2021
· Device
Terminated
Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Small, 8 mm, Product Number...
Mar 17, 2021
· Device
Terminated
Accurian RF Ablation, Cannula pk, Accurian, 100mm, 20G, 10mm, CS Product Number: AC0009 GTIN / UPN: 2076300015...
Jun 8, 2020
· Device
Terminated
Accurian RF Ablation, Cannula pk, Accurian, 150mm, 18G, 10mm, CS Product Number: AC0007 GTIN / UPN: 2076300015...
Jun 8, 2020
· Device
Terminated
Accurian RF Ablation, Cannula pk, Accurian, 100mm, 22G, 5mm, CS Product Number: AC0016 GTIN / UPN: 20763000153...
Jun 8, 2020
· Device
Terminated
Accurian RF Ablation, Cannula pk, Accurian, 100mm, 18G, 10mm, CS Product Number: AC0005 GTIN /UPN: 20763000153...
Jun 8, 2020
· Device
Terminated
Accurian RF Ablation,Cannula pk, Accurian, 100mm, 22G, 10mm, SS Product Number: AC0019 GTIN / UPN: 20763000153...
Jun 8, 2020
· Device
Terminated
Accurian RF Ablation, Cannula pk, Accurian, 150mm, 20G, 10mm, CS Product Number: AC0012 GTIN / UPN: 2076300015...
Jun 8, 2020
· Device
Terminated
Extremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, moldable and biocompatible calcium ph...
Apr 24, 2020
· Device
Terminated
Medtronic Bone Void Filler, Large - Product Usage:
is an injectable, moldable and biocompatible calcium phos...
Apr 24, 2020
· Device
Terminated
Medtronic Bone Void Filler, Small - Product Usage:
is an injectable, moldable and biocompatible calcium phos...
Apr 24, 2020
· Device
Terminated
VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628
Mar 26, 2020
· Device
Terminated