Medtronic Sofamor Danek Usa recalls
Medtronic Sofamor Danek Usa appears in 87 official U.S. recall notices indexed by RecallRadar, most recently on 2026-10-21.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 87 |
|---|---|
| Published | 2012-10-17 to 2026-10-21 |
| By agency | FDA Device (87) |
| By classification | Class II (87) |
| By status | terminated (50), ongoing (37) |
| Distribution named in notices | AR, CA, CT, FL, GA, IA, IN, KS, KY, MA, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TX, US, WA, WV |
Recalls
- Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone ma…
FDA Device · Class II · 2026-10-21 · Medtronic Sofamor Danek Usa
Reason: Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related to the presence of microbial organisms. While the batch passed… - Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone ma…
FDA Device · Class II · 2026-10-21 · Medtronic Sofamor Danek Usa
Reason: Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related to the presence of microbial organisms. While the batch passed… - Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073 CATALYFT PL SHORT 7MM…
FDA Device · Class II · 2025-12-03 · Medtronic Sofamor Danek Usa
Reason: Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be up… - Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210
FDA Device · Class II · 2023-11-01 · Medtronic Sofamor Danek Usa
Reason: Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have bee… - Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f) T43110, g) T43110INT
FDA Device · Class II · 2023-11-01 · Medtronic Sofamor Danek Usa
Reason: Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have bee… - Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280
FDA Device · Class II · 2023-11-01 · Medtronic Sofamor Danek Usa
Reason: Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have bee… - Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix
FDA Device · Class II · 2023-11-01 · Medtronic Sofamor Danek Usa
Reason: Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have bee… - Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150
FDA Device · Class II · 2023-11-01 · Medtronic Sofamor Danek Usa
Reason: Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have bee… - Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix
FDA Device · Class II · 2023-11-01 · Medtronic Sofamor Danek Usa
Reason: Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have bee… - Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010
FDA Device · Class II · 2023-11-01 · Medtronic Sofamor Danek Usa
Reason: Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have bee… - Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile
FDA Device · Class II · 2023-09-20 · Medtronic Sofamor Danek Usa
Reason: The incorrect product labeling was applied to the product indicating the wrong size of product. - CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
FDA Device · Class II · 2023-08-16 · Medtronic Sofamor Danek Usa
Reason: Incorrect Laser Marking - Solera Awl Tip Tap - Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027722, spinal implant
FDA Device · Class II · 2023-07-19 · Medtronic Sofamor Danek Usa
Reason: There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral… - Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage, REF SPS03188, spinal implant kit
FDA Device · Class II · 2023-07-19 · Medtronic Sofamor Danek Usa
Reason: There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral… - Medtronic Catalyft LS Expandable Interbody System, Anterier Standalone Cage, REF 981023322, spinal implant
FDA Device · Class II · 2023-07-19 · Medtronic Sofamor Danek Usa
Reason: There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral… - Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025525, spinal implant
FDA Device · Class II · 2023-07-19 · Medtronic Sofamor Danek Usa
Reason: There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral… - Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027725, spinal implant
FDA Device · Class II · 2023-07-19 · Medtronic Sofamor Danek Usa
Reason: There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral… - Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981023325, spinal implant
FDA Device · Class II · 2023-07-19 · Medtronic Sofamor Danek Usa
Reason: There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral… - Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025522, spinal implant
FDA Device · Class II · 2023-07-19 · Medtronic Sofamor Danek Usa
Reason: There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral… - Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139
FDA Device · Class II · 2023-05-17 · Medtronic Sofamor Danek Usa
Reason: Two lots of the 5598007 Distractor Rack which were not manufactured to specification. The crest width of the gear is too wide and may cause difficulty or the inability to operate the Distractor. - INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 34mm, REF 3604034
FDA Device · Class II · 2023-04-26 · Medtronic Sofamor Danek Usa
Reason: Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws - INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 32mm, REF 3604532
FDA Device · Class II · 2023-04-26 · Medtronic Sofamor Danek Usa
Reason: Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws - INFINITY Occipitocervical Upper Thoracic System, PARTIALLY THREADED MULTI AXIAL SCREW, Size: 4.0mm x 22mm, REF 360PT4022
FDA Device · Class II · 2023-04-26 · Medtronic Sofamor Danek Usa
Reason: Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws - INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 26mm, REF 3604026
FDA Device · Class II · 2023-04-26 · Medtronic Sofamor Danek Usa
Reason: Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws - INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm, REF 3604024
FDA Device · Class II · 2023-04-26 · Medtronic Sofamor Danek Usa
Reason: Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws - Medtronic Accelerate Grafton DBF a) ACCELERATE BG SET T50203 GRAFTON DBF 3CC, REF T50203
FDA Device · Class II · 2023-04-12 · Medtronic Sofamor Danek Usa
Reason: Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier. - Medtronic Grafton Crunch a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105
FDA Device · Class II · 2023-04-12 · Medtronic Sofamor Danek Usa
Reason: Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier. - Medtronic XPANSE Bone Insert: a) DBM T600106 XPANSE SMALL-C 6, REF T600106
FDA Device · Class II · 2023-04-12 · Medtronic Sofamor Danek Usa
Reason: Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier. - Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF S42200
FDA Device · Class II · 2023-04-12 · Medtronic Sofamor Danek Usa
Reason: Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier. - Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303
FDA Device · Class II · 2023-04-12 · Medtronic Sofamor Danek Usa
Reason: Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier. - Medtronic Grafton Gel: a) DBM S41120 GRAFTON GEL 1CC, REF S41120
FDA Device · Class II · 2023-04-12 · Medtronic Sofamor Danek Usa
Reason: Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier. - Medtronic Grafton Plus Paste a) DBM S45001 GRAFTON 1CC PASTE, REF S45001
FDA Device · Class II · 2023-04-12 · Medtronic Sofamor Danek Usa
Reason: Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier. - Medtronic Grafton DBF: a) PUTTY T50101 GRAFTON DBF 1CC, REF T50101
FDA Device · Class II · 2023-04-12 · Medtronic Sofamor Danek Usa
Reason: Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier. - Medtronic Grafton Flex: a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S42090
FDA Device · Class II · 2023-04-12 · Medtronic Sofamor Danek Usa
Reason: Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier. - Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101
FDA Device · Class II · 2023-04-12 · Medtronic Sofamor Danek Usa
Reason: Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier. - Medtronic Grafton Orthoblend: a) DBM S44125 5CC ORTHOBLEND LARGE DEFECT, REF S44125
FDA Device · Class II · 2023-04-12 · Medtronic Sofamor Danek Usa
Reason: Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier. - Medtronic Grafton Matrix Strips: a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STRPS, REF S42275
FDA Device · Class II · 2023-04-12 · Medtronic Sofamor Danek Usa
Reason: Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier. - Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm
FDA Device · Class II · 2021-10-20 · Medtronic Sofamor Danek Usa
Reason: Engraving on implants may not match what is listed on the pouch labels. - Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm
FDA Device · Class II · 2021-10-20 · Medtronic Sofamor Danek Usa
Reason: Engraving on implants may not match what is listed on the pouch labels. - Braive Growth Modulation System Break-Off Set Screws - Product Usage: intended to limit further progression of the spinal curvature and pro…
FDA Device · Class II · 2021-06-16 · Medtronic Sofamor Danek Usa
Reason: Product is impacted by a thread profile defect due to a manufacturing issue. - Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Small, 8 mm, Product Number 5146-1208-N - Product Usage:…
FDA Device · Class II · 2021-04-28 · Medtronic Sofamor Danek Usa
Reason: The shelf box identifies a small device actually contains a large device, and the shelf box identifying a large device actually contains a small device. - Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Large, 8 mm, Product Number 5146-1608-N - Product Usage:…
FDA Device · Class II · 2021-04-28 · Medtronic Sofamor Danek Usa
Reason: The shelf box identifies a small device actually contains a large device, and the shelf box identifying a large device actually contains a small device. - Accurian RF Ablation, Cannula pk, Accurian, 150mm, 18G, 10mm, CS Product Number: AC0007 GTIN / UPN: 20763000153568 - Product Usage: (steril…
FDA Device · Class II · 2020-07-29 · Medtronic Sofamor Danek Usa
Reason: Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. - Accurian RF Ablation, Cannula pk, Accurian, 100mm, 18G, 10mm, CS Product Number: AC0005 GTIN /UPN: 20763000153551 - Product Usage: (sterile…
FDA Device · Class II · 2020-07-29 · Medtronic Sofamor Danek Usa
Reason: Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. - Accurian RF Ablation, Cannula pk, Accurian, 150mm, 20G, 10mm, CS Product Number: AC0012 GTIN / UPN: 20763000153629 - Product Usage: (steril…
FDA Device · Class II · 2020-07-29 · Medtronic Sofamor Danek Usa
Reason: Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. - Accurian RF Ablation, Cannula pk, Accurian, 100mm, 22G, 5mm, CS Product Number: AC0016 GTIN / UPN: 20763000153674 - Product Usage: (sterile…
FDA Device · Class II · 2020-07-29 · Medtronic Sofamor Danek Usa
Reason: Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. - Accurian RF Ablation, Cannula pk, Accurian, 100mm, 20G, 10mm, CS Product Number: AC0009 GTIN / UPN: 20763000153599 - Product Usage: (steril…
FDA Device · Class II · 2020-07-29 · Medtronic Sofamor Danek Usa
Reason: Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. - Accurian RF Ablation,Cannula pk, Accurian, 100mm, 22G, 10mm, SS Product Number: AC0019 GTIN / UPN: 20763000153667 - Product Usage: (sterile…
FDA Device · Class II · 2020-07-29 · Medtronic Sofamor Danek Usa
Reason: Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. - Medtronic Bone Void Filler, Large - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler
FDA Device · Class II · 2020-06-24 · Medtronic Sofamor Danek Usa
Reason: Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the required surgical and anesthesi… - Medtronic Bone Void Filler, Small - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler
FDA Device · Class II · 2020-06-24 · Medtronic Sofamor Danek Usa
Reason: Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the required surgical and anesthesi…