The Recall Desk

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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • 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
  • 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-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
  • 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
  • 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-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-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-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-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-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-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-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-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…
    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…
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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…
    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…
    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-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…
    Category
    Medical Device
    Distribution
    Distributed nationwide