Medtronic Sofamor Danek USA Inc

Complete recall history across all FDA and CPSC categories — 81 total recalls

Medtronic Sofamor Danek USA Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (81)

FDA medical device enforcement actions by Medtronic Sofamor Danek USA Inc. Showing most recent 50.

Date Product Reason Class
Sep 16, 2025 Catalyft PL & PL40 Expandable Interbody System labeled as follows with corres... Expandable interbody system cage may loose height or collapse (loss of lordos... Class II
Sep 26, 2023 Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix Specific serial numbers of GraftonTM DBM product due to the potential that a ... Class II
Sep 26, 2023 Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; Demineralized... Specific serial numbers of GraftonTM DBM product due to the potential that a ... Class II
Sep 26, 2023 Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T... Specific serial numbers of GraftonTM DBM product due to the potential that a ... Class II
Sep 26, 2023 Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demin... Specific serial numbers of GraftonTM DBM product due to the potential that a ... Class II
Sep 26, 2023 Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d)... Specific serial numbers of GraftonTM DBM product due to the potential that a ... Class II
Sep 26, 2023 Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone M... Specific serial numbers of GraftonTM DBM product due to the potential that a ... Class II
Sep 26, 2023 Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix Specific serial numbers of GraftonTM DBM product due to the potential that a ... Class II
Jul 31, 2023 Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, De... The incorrect product labeling was applied to the product indicating the wron... Class II
Jun 6, 2023 Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, ... There is the potential for out of specification device geometries. widths, l... Class II
Jun 6, 2023 Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, ... There is the potential for out of specification device geometries. widths, l... Class II
Jun 6, 2023 Medtronic Catalyft LS Expandable Interbody System, Anterier Standalone Cage, ... There is the potential for out of specification device geometries. widths, l... Class II
Jun 6, 2023 Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, ... There is the potential for out of specification device geometries. widths, l... Class II
Jun 6, 2023 Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, ... There is the potential for out of specification device geometries. widths, l... Class II
Jun 6, 2023 Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, ... There is the potential for out of specification device geometries. widths, l... Class II
Jun 6, 2023 Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Stand... There is the potential for out of specification device geometries. widths, l... Class II
Feb 16, 2023 INFINITY Occipitocervical Upper Thoracic System, PARTIALLY THREADED MULTI AXI... Incorrect type of titanium was used which reduces the gripping strength of th... Class II
Feb 16, 2023 INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.... Incorrect type of titanium was used which reduces the gripping strength of th... Class II
Feb 16, 2023 INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.... Incorrect type of titanium was used which reduces the gripping strength of th... Class II
Feb 16, 2023 INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.... Incorrect type of titanium was used which reduces the gripping strength of th... Class II
Feb 16, 2023 INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.... Incorrect type of titanium was used which reduces the gripping strength of th... Class II
Feb 8, 2023 Medtronic Grafton Flex: a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S420... Potential for packaging non-conformances directly related to the dual-barrier... Class II
Feb 8, 2023 Medtronic Accelerate Grafton DBF a) ACCELERATE BG SET T50203 GRAFTON DBF 3C... Potential for packaging non-conformances directly related to the dual-barrier... Class II
Feb 8, 2023 Medtronic Grafton DBF: a) PUTTY T50101 GRAFTON DBF 1CC, REF T50101; b) ... Potential for packaging non-conformances directly related to the dual-barrier... Class II
Feb 8, 2023 Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101; ... Potential for packaging non-conformances directly related to the dual-barrier... Class II
Feb 8, 2023 Medtronic Grafton Matrix Strips: a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STR... Potential for packaging non-conformances directly related to the dual-barrier... Class II
Feb 8, 2023 Medtronic Grafton Plus Paste a) DBM S45001 GRAFTON 1CC PASTE, REF S45001; ... Potential for packaging non-conformances directly related to the dual-barrier... Class II
Feb 8, 2023 Medtronic Grafton Orthoblend: a) DBM S44125 5CC ORTHOBLEND LARGE DEFECT, R... Potential for packaging non-conformances directly related to the dual-barrier... Class II
Feb 8, 2023 Medtronic Grafton Gel: a) DBM S41120 GRAFTON GEL 1CC, REF S41120; b) DBM ... Potential for packaging non-conformances directly related to the dual-barrier... Class II
Feb 8, 2023 Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF... Potential for packaging non-conformances directly related to the dual-barrier... Class II
Feb 8, 2023 Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; ... Potential for packaging non-conformances directly related to the dual-barrier... Class II
Feb 8, 2023 Medtronic XPANSE Bone Insert: a) DBM T600106 XPANSE SMALL-C 6, REF T600106;... Potential for packaging non-conformances directly related to the dual-barrier... Class II
Feb 8, 2023 Medtronic Grafton Crunch a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105; b)... Potential for packaging non-conformances directly related to the dual-barrier... Class II
Nov 19, 2021 Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set... Two lots of the 5598007 Distractor Rack which were not manufactured to specif... Class II
Sep 2, 2021 Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, N... Engraving on implants may not match what is listed on the pouch labels. Class II
Sep 2, 2021 Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, N... Engraving on implants may not match what is listed on the pouch labels. Class II
Jun 8, 2020 Accurian RF Ablation, Cannula pk, Accurian, 100mm, 18G, 10mm, CS Product Numb... Insertion difficulty of the probes. The probe was catching on a lip inside ... Class II
Jun 8, 2020 Accurian RF Ablation, Cannula pk, Accurian, 150mm, 18G, 10mm, CS Product Numb... Insertion difficulty of the probes. The probe was catching on a lip inside ... Class II
Jun 8, 2020 Accurian RF Ablation, Cannula pk, Accurian, 100mm, 20G, 10mm, CS Product Numb... Insertion difficulty of the probes. The probe was catching on a lip inside ... Class II
Jun 8, 2020 Accurian RF Ablation,Cannula pk, Accurian, 100mm, 22G, 10mm, SS Product Numbe... Insertion difficulty of the probes. The probe was catching on a lip inside ... Class II
Jun 8, 2020 Accurian RF Ablation, Cannula pk, Accurian, 100mm, 22G, 5mm, CS Product Numbe... Insertion difficulty of the probes. The probe was catching on a lip inside ... Class II
Jun 8, 2020 Accurian RF Ablation, Cannula pk, Accurian, 150mm, 20G, 10mm, CS Product Numb... Insertion difficulty of the probes. The probe was catching on a lip inside ... Class II
Apr 24, 2020 Medtronic Bone Void Filler, Large - Product Usage: is an injectable, moldab... Product may not maintain its setting characteristics for the labeled shelf-li... Class II
Apr 24, 2020 Extremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, mold... Product may not maintain its setting characteristics for the labeled shelf-li... Class II
Apr 24, 2020 Medtronic Bone Void Filler, Small - Product Usage: is an injectable, moldab... Product may not maintain its setting characteristics for the labeled shelf-li... Class II
Mar 26, 2020 VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628 Nonconforming product; length of the product measured shorter than the label... Class II
Sep 27, 2018 INFUSE Bone Graft X SMALL KIT REF 7510100 The Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two ab... Class II
Jul 9, 2018 Medtronic CD HORIZON Spinal System is intended to help provide immobilization... This lot has incorrectly been laser marked both on the screw head itself as w... Class II
Mar 23, 2018 Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Si... Slot screw had an overall length of 15mm, but per the specification, the scre... Class II
Mar 13, 2018 Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, ... The firm received complaints of drill bits breaking during use with the Prest... Class II

View all 81 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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