Manufacturer

Medtronic Sofamor Danek USA, Inc

85 recalls in our database name Medtronic Sofamor Danek USA, Inc as the manufacturing or recalling firm.

What the numbers show

Total: 85
Critical: 0
Severe: 1
Most recent: 2025-12-03

Of the 85 recalls from Medtronic Sofamor Danek USA, Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (1%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–50 of 85

HighFDA (Devices)·Z-1326-2023·2023-04-12
Medtronic Grafton Orthoblend Surgical Bone Graft Packaging Defect Recall
Medtronic recalls Grafton Orthoblend bone graft products due to potential sterile packaging defects that could compromise product sterility. The packaging non-conformances may allow breach of the dual-barrier protection system.
Product
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 ORT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1323-2023·2023-04-12
Medtronic Grafton Putty Bone Matrix Packaging Sterile Barrier Non-Conformance
Medtronic recalls 186,889 units of Grafton Putty demineralized bone matrix product due to potential packaging defects that could compromise sterile barrier integrity. No illnesses reported.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1327-2023·2023-04-12
Medtronic Grafton Matrix Bone Graft Packaging Sterility Concerns
Medtronic is recalling Grafton Matrix bone graft products due to potential packaging defects that could compromise sterility. A total of 19,057 units were distributed worldwide.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1330-2023·2023-04-12
Medtronic Grafton DBF Bone Matrix Sterile Packaging Barrier Defect Recall
Medtronic is recalling Grafton DBF bone matrix products due to potential packaging defects in the dual-barrier sterile pouch system. The defects could lead to a breach in the sterile barrier.
Product
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) P
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1333-2023·2023-04-12
Medtronic Grafton Gel Surgical Implant Sterile Barrier Packaging Recall
Medtronic is recalling Grafton Gel demineralized bone matrix surgical implants due to packaging non-conformances in the sterile pouch that could compromise the sterile barrier of the implant.
Product
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 T41120IN
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1329-2023·2023-04-12
Medtronic Grafton Plus Paste surgical implant recall due to packaging defects
Medtronic is recalling 37,721 units of Grafton Plus Paste surgical implant material due to potential packaging defects in the sterile pouch system that could compromise sterile barrier integrity.
Product
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 T4500
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1325-2023·2023-04-12
Medtronic Grafton Flex bone graft products recalled for packaging integrity defects
Medtronic is recalling Grafton Flex demineralized bone matrix products due to potential packaging non-conformances that could compromise sterile barrier integrity. Approximately 2,987 units were distributed worldwide.
Product
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 G
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1332-2023·2023-04-12
Medtronic Accelerate Grafton DBF Bone Matrix Packaging Defect Recall
Medtronic is recalling Accelerate Grafton DBF bone matrix products due to potential packaging non-conformances in the sterile pouch system that may compromise the sterile barrier. The recall affects 3,037 units distributed worldwide.
Product
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; Deminera
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1328-2023·2023-04-12
Medtronic Grafton Matrix surgical strips: potential sterile barrier packaging defects
Medtronic is recalling Grafton Matrix Strips due to potential defects in the sterile packaging barrier. Non-conforming packaging could allow sterile barrier compromise in this surgical implant product.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1331-2023·2023-04-12
Medtronic Grafton DBF Inject bone matrix products recalled for packaging defects
Medtronic is recalling Grafton DBF Inject demineralized bone matrix products due to potential packaging non-conformances that may compromise the sterile barrier. Over 10,000 units distributed worldwide are affected.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0086-2022·2021-10-20
Endoskeleton TCS Interbody System implant engraving may not match pouch labels
Medtronic is recalling 9 Endoskeleton TCS Interbody System surgical implants because engraving on the devices may not match the labels on the pouches. The mismatch could result in wrong devices being implanted.
Product
Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-0085-2022·2021-10-20
Spinal Implant Engraving May Not Match Pouch Labels
Medtronic Sofamor Danek is recalling the Endoskeleton TAS Interbody System because the engraving on the implants may not match the information on the pouch labels.
Product
Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-1797-2021·2021-06-16
Medtronic Braive Growth Modulation System Break-Off Set Screws Recalled for Thread Defect
Medtronic is recalling Braive Growth Modulation System Break-Off Set Screws due to a thread profile defect caused by a manufacturing issue. The defect may affect proper device function.
Product
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.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1440-2021·2021-04-28
Medtronic Endoskeleton TC Interbody System Recalled for Packaging Labeling Error
Medtronic is recalling 11 Endoskeleton TC Interbody System devices because shelf boxes were mislabeled, containing the wrong size device.
Product
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 comprise
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1439-2021·2021-04-28
Medtronic Endoskeleton TC Interbody System Recalled for Incorrect Size Labeling
Medtronic is recalling 11 Endoskeleton TC Interbody System devices because shelf boxes misidentify the size of the contained device.
Product
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 comprise
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2691-2020·2020-07-29
Medtronic Recalls Accurian RF Ablation Cannulas Due to Insertion Difficulty
Medtronic is recalling Accurian RF Ablation Cannulas because the probes may catch on a lip inside the hub, causing insertion difficulty.
Product
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,
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2693-2020·2020-07-29
Medtronic Accurian RF Ablation Cannula Recalled for Insertion Difficulty
Medtronic is recalling Accurian RF Ablation Cannulas because the probes catch on a lip inside the hub, causing insertion difficulty.
Product
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,
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2690-2020·2020-07-29
Medtronic Accurian RF Ablation Cannula Recalled for Insertion Difficulty
Medtronic is recalling Accurian RF Ablation Cannulas because the probe catches on a lip inside the hub, causing insertion difficulty.
Product
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, a
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2694-2020·2020-07-29
Medtronic Accurian RF Ablation Cannula Recalled for Insertion Difficulty
Medtronic is recalling Accurian RF Ablation Cannulas because the probe catches on a lip inside the hub, causing insertion difficulty.
Product
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, a
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2695-2020·2020-07-29
Medtronic Accurian RF Ablation Cannula Recalled for Insertion Difficulty
Medtronic is recalling Accurian RF Ablation Cannulas because the probe catches on a lip inside the hub, causing insertion difficulty.
Product
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,
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2692-2020·2020-07-29
Medtronic Accurian RF Ablation Cannula Recall for Insertion Difficulty
Medtronic is recalling Accurian RF Ablation Cannulas because the probe may catch on a lip inside the hub, causing insertion difficulty.
Product
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,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2391-2020·2020-06-24
Medtronic Bone Void Filler Recalled for Potential Setting Defects
Medtronic is recalling 6 units of Bone Void Filler, Large, because the product may not maintain its setting characteristics for the labeled shelf-life.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2389-2020·2020-06-24
Medtronic Bone Void Filler Kit Recalled for Setting Defects
Medtronic is recalling 41 units of Bone Void Filler Kits because the product may not set properly, potentially increasing surgical time and causing incomplete bone formation.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2390-2020·2020-06-24
Medtronic Bone Void Filler Recalled for Potential Setting Defects
Medtronic is recalling 36 units of Bone Void Filler, Small, because the product may not maintain its setting characteristics for the labeled shelf-life, potentially increasing surgical time.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1941-2020·2020-05-20
Medtronic Recalls Vertex Select Multi Axial Screws Due to Length Discrepancy
Medtronic is recalling 83 Vertex Select Multi Axial Screws because the product length is shorter than labeled. The recall covers units distributed in California and Michigan.
Product
VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628
Category
Medical Device
Distribution
Distributed nationwide