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.

1–25 of 85

HighFDA (Devices)·Z-0580-2026·2025-12-03
Expandable spinal cages recalled because they may lose height or collapse
Medtronic Sofamor Danek is recalling 275,260 Catalyft PL and PL40 expandable interbody spacers because the cage may lose height or collapse, risking migration or neurological injury.
Product
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, Mo
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0166-2024·2023-11-01
Grafton Plus DBM Paste medical device recalled for packaging inspection failure
Medtronic is recalling Grafton Plus DBM Paste due to a missed inspection step on the outer packaging. The outer Tyvek pouch may have non-conformances that could affect product integrity.
Product
Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0161-2024·2023-11-01
Medtronic Grafton DBM Crunch surgical implant packaging inspection defect
Medtronic is recalling Grafton DBM Crunch bone matrix surgical implants due to potential packaging defects in the outer Tyvek pouch. An inspection step may not have been completed according to requirements.
Product
Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0165-2024·2023-11-01
Grafton DBM Orthoblend Recall Due to Sterile Packaging Inspection Issue
Medtronic Sofamor Danek USA Inc is recalling specific batches of Grafton DBM Orthoblend, an orthopedic implant material, because a required sterile packaging inspection step may not have been performed according to specifications.
Product
Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; Demineralized Bone Matrix
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0162-2024·2023-11-01
Grafton DBM Demineralized Bone Matrix Recall Due to Sterile Packaging Inspection Failure
Medtronic is recalling 77 units of Grafton DBM (Flex) due to a potential failure to perform required inspection of the outer Tyvek sterile pouch. Affected units may not meet sterile packaging standards.
Product
Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0167-2024·2023-11-01
Grafton DBM Putty bone matrix implants recalled for packaging defects
Medtronic is recalling Grafton DBM Putty bone matrix implants because the outer Tyvek pouch inspection step may not have been performed, potentially releasing non-conforming batches.
Product
Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f) T43110, g) T43110INT; Demineralized Bone Matrix
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0164-2024·2023-11-01
Grafton DBM Matrix Strips Recalled for Packaging Inspection Defect
Medtronic is recalling specific serial numbers of Grafton DBM Matrix Strips due to a potential defect in the outer Tyvek pouch resulting from a missed inspection step during manufacturing.
Product
Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; Demineralized Bone Matrix
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0163-2024·2023-11-01
Grafton DMB Matrix bone graft recalled for potential outer pouch defects
Medtronic is recalling 377 units of Grafton DMB Matrix demineralized bone matrix devices due to potential defects in the outer Tyvek pouch from a missed manufacturing inspection step. No patient injuries have been reported.
Product
Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2524-2023·2023-09-20
Medtronic Bone Graft Recalled Due to Incorrect Size Labeling
Medtronic Sofamor Danek USA Inc is recalling Magnifuse Bone Graft products due to incorrect size labeling on 55 pouches. Units with specific serial numbers were distributed in nine U.S. states.
Product
Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2363-2023·2023-08-16
Surgical Spinal Tap Device Recalled for Incorrect Laser Marking
Medtronic is recalling Solera Awl Tip Tap surgical devices due to incorrect laser marking. Thirteen devices were distributed in Florida, Colorado, Indiana, South Carolina, Texas, and Utah.
Product
CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2123-2023·2023-07-19
Medtronic Catalyft LS Spinal Implant Recalled for Out-of-Specification Geometry
Medtronic recalls Catalyft LS spinal implants due to potential out-of-specification dimensions. The affected devices may not properly fit or function as intended during spine fusion surgery.
Product
Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage, REF SPS03188, spinal implant kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2121-2023·2023-07-19
Medtronic Catalyft LS Spinal Implant Recall Due to Out-of-Specification Geometry
Medtronic recalls 10 units of Catalyft LS spinal implants due to potential out-of-specification device geometries. The affected implants may not properly support or accommodate patient anatomy during lumbar fusion surgery.
Product
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027722, spinal implant
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2119-2023·2023-07-19
Medtronic Catalyft LS Spinal Implants Recalled for Out-of-Specification Dimensions
Medtronic recalls 25 units of Catalyft LS spinal implants (lot numbers NM21J039, NM21M026) due to out-of-specification device dimensions that may affect surgical fit and function.
Product
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025522, spinal implant
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2117-2023·2023-07-19
Medtronic spinal implant recall due to out-of-specification device dimensions
Medtronic Catalyft LS Expandable Interbody System spinal implants are being recalled due to out-of-specification device dimensions that may affect proper placement and spinal support.
Product
Medtronic Catalyft LS Expandable Interbody System, Anterier Standalone Cage, REF 981023322, spinal implant
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2120-2023·2023-07-19
Medtronic Catalyft LS Spinal Implants Recalled for Out-of-Specification Geometry
Medtronic is recalling 11 units of its Catalyft LS Expandable Interbody System spinal implants due to potential out-of-specification dimensions that could affect surgical fit and stability.
Product
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025525, spinal implant
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2122-2023·2023-07-19
Medtronic Catalyft LS Spinal Implant Recall for Out-of-Spec Geometry
Medtronic is recalling Catalyft LS spinal implants due to potential out-of-specification device geometries that may not properly accommodate patient anatomy.
Product
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027725, spinal implant
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2118-2023·2023-07-19
Medtronic Catalyft LS spinal implant recalled for out-of-specification device dimensions
Medtronic is recalling eight units of Catalyft LS Expandable Interbody System spinal implants due to potential out-of-specification device dimensions that could affect surgical fitting and spinal stability.
Product
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981023325, spinal implant
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1574-2023·2023-05-17
Medtronic Spinal Distractor Rack Recalled for Manufacturing Defect
Medtronic is recalling Distractor Rack devices used in spinal surgery due to manufacturing defects that may prevent proper device operation. Two lot numbers are affected and were distributed to facilities in Indiana, Connecticut, and Nebraska.
Product
Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in spinal surgery
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1411-2023·2023-04-26
Spinal Implant Screws Recalled for Defective Titanium Material
Medtronic is recalling INFINITY spinal implant screws manufactured with incorrect titanium material. The defect reduces the screw's gripping strength, risking implant performance in critical spinal fusion surgery.
Product
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 unctio
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1409-2023·2023-04-26
Spinal implant screws recalled due to defective titanium material
Medtronic is recalling 45 units of INFINITY Multi-Axial Screws (lot H5802983) worldwide because incorrect titanium was used, reducing the screw head's gripping strength. No illnesses or injuries have been reported.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1412-2023·2023-04-26
Spinal fixation screws recalled for reduced titanium gripping strength
Medtronic is recalling 90 INFINITY Multi-Axial Screws (Lot H5806345) due to incorrect titanium material that reduces screw head gripping strength. The defect affects 5 batches distributed in the US and Canada.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1410-2023·2023-04-26
Medtronic INFINITY Spinal Fusion Screws Recalled for Material Defect
Medtronic is recalling 10 units of INFINITY Multi-Axial Screws distributed in the US and Canada because incorrect titanium material reduces gripping strength in affected lots.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1413-2023·2023-04-26
INFINITY Multi-Axial Spinal Screws Recalled for Titanium Material Defect
Medtronic is recalling INFINITY Multi-Axial Spinal Screws due to incorrect titanium material used in manufacturing, which reduces the gripping strength of the screw head. The affected screws are used for spinal fusion and stabilization.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
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-1324-2023·2023-04-12
Medtronic Grafton Crunch sterile pouch packaging non-conformance recall
Medtronic is recalling Grafton Crunch demineralized bone matrix products due to potential packaging non-conformances that may compromise sterile barriers. 5,308 units are affected globally.
Product
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) DB
Category
Medical Device
Distribution
Distributed nationwide