Memphis, TN, United States

Medtronic Sofamor Danek USA Inc recalls

21 recalls recorded since 2018, most recently on 12 August 2026. 9 are listed as ongoing. Status and classification are as published by the FDA.

Recalls21

Ongoing (FDA)9

Terminated or completed12

Class I (FDA)0

Ongoing Class II Medical devices

Recall started: 12 August 2026
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 finished product sterility testing Medtronic is retrieving any unused product manufactured from the donor tissue. Donor bone tissue tested positive for Clostridium butyricum and while tissue did undergo gamma radiation, if implanted, there is a possibility of clostridium infection.
Distribution: US Nationwide distribution in the states of OK, VA, CO, AR, FL, TX, MD, DE, IL, MI, KS, AL, GA.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0138-2027, Z-0137-2027

Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone matrix (DBM) allograft product having a particular physical form and/or handling pr
Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone matrix (DBM) allograft product having a particular physical form and/or handling

Ongoing Class II Medical devices

Recall started: 16 September 2025
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 updated to mitigate risk of loss of lordosis to occur.
Distribution: Worldwide distribution - US Nationwide and Puerto Rico. The countries of Australia, Austria, Belgium, Canada, Croatia, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Netherlands, New Caledonia, New Zealand, Norway, Portugal, Reunion, Saudi Arabia,
Initiated: Voluntary: Firm initiated
Recall number: Z-0580-2026

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 Numb

Ongoing Class II Medical devices

Recall started: 26 September 2023
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 been released with potential non-conformances in the outer Tyvek pouch.
Distribution: US, Colombia, S. Korea, New Zealand, India, Taiwan
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0162-2024, Z-0163-2024, Z-0165-2024, Z-0166-2024, Z-0167-2024, Z-0164-2024, Z-0161-2024

Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix
Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix
Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; Demineralized Bone Matrix
Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix
Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f) T43110, g) T43110INT; Demineralized Bone Matrix
Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; Demineralized Bone Matrix
Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix

Ongoing Class II Medical devices

Recall started: 31 July 2023
Reason: The incorrect product labeling was applied to the product indicating the wrong size of product.
Distribution: US Nationwide distribution in the states of ID, IN, MN, NC, NY, OH, OR, WA, and WI.
Initiated: Voluntary: Firm initiated
Recall number: Z-2524-2023

Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile.

Ongoing Class II Medical devices

Recall started: 12 July 2023
Reason: Incorrect Laser Marking - Solera Awl Tip Tap
Distribution: US Nationwide distribution in the states of FL, CO, IN, SC, TX, UT.
Initiated: Voluntary: Firm initiated
Recall number: Z-2363-2023

CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K

Ongoing Class II Medical devices

Recall started: 6 June 2023
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 bodies to give support and correction during lumbar interbody fusion surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or Corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.
Distribution: US Nationwide distribution in the states of IN, WI, GA, OR, AR, OH, TN, TX, NC, OR, NE, MN, FL.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2123-2023, Z-2121-2023, Z-2122-2023, Z-2118-2023, Z-2117-2023, Z-2120-2023, Z-2119-2023

Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage, REF SPS03188, spinal implant kit
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027722, spinal implant
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027725, spinal implant
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981023325, spinal implant
Medtronic Catalyft LS Expandable Interbody System, Anterier Standalone Cage, REF 981023322, spinal implant
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025525, spinal implant
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025522, spinal implant

Ongoing Class II Medical devices

Recall started: 16 February 2023
Reason: Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1409-2023, Z-1412-2023, Z-1410-2023, Z-1413-2023, Z-1411-2023

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 ins
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 ins
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 ins
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 ins
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

Ongoing Class II Medical devices

Recall started: 8 February 2023
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.
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Brunei Darussalam, Canada, Chile, Colombia, Denmark, Dominican Republic, Ecuador, Finland, Ghana, Greece, Guatemala, Hong Kong, India, Ireland, Israel, Jamaica, Japan, Jordan, Korea, Republic Of, Kuwait, Lebanon, Liechte
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1331-2023, Z-1327-2023, Z-1324-2023, Z-1334-2023, Z-1333-2023, Z-1326-2023, Z-1329-2023, Z-1328-2023, Z-1323-2023, Z-1330-2023, Z-1332-2023, Z-1325-2023

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
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
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 T44105I
Medtronic XPANSE Bone Insert: a) DBM T600106 XPANSE SMALL-C 6, REF T600106; b) DBM T600206 XPANSE MEDIUM-C 6, REF T600206; c) DBM T600209 XPANSE MEDIUM-C 9, REF T600209; d) DBM T600306 XPANSE LARGE-C 6, REF T6
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;
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
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
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 T
and 4 more product lines

Ongoing Class II Medical devices

Recall started: 19 November 2021
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.
Distribution: US: IN, CT, NE
Initiated: Voluntary: Firm initiated
Recall number: Z-1574-2023

Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in spinal surgery

Terminated Class II Medical devices

Recall started: 2 September 2021
Terminated: 5 October 2023
Reason: Engraving on implants may not match what is listed on the pouch labels.
Distribution: Distribution in US: CA, MN, MO, NC, NV, NY, OH, OK, OR, PA, SC, SD, WA, WV
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0086-2022, Z-0085-2022

Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm
Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm

Terminated Class II Medical devices

Recall started: 27 April 2021
Terminated: 20 August 2024
Reason: Product is impacted by a thread profile defect due to a manufacturing issue.
Distribution: International distribution in the countries of France, Switzerland and Jordan. No US distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-1797-2021

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

Terminated Class II Medical devices

Recall started: 17 March 2021
Terminated: 3 May 2023
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.
Distribution: US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1440-2021, Z-1439-2021

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 th
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 th

Terminated Class II Medical devices

Recall started: 8 June 2020
Terminated: 10 May 2022
Reason: Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
Distribution: Worldwide distribution - US Nationwide distribution and the countries of Belgium and Australia.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2693-2020, Z-2694-2020, Z-2695-2020, Z-2692-2020, Z-2691-2020, Z-2690-2020

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
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
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 fo
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
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
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

Terminated Class II Medical devices

Recall started: 24 April 2020
Terminated: 31 March 2021
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 anesthesia time for the patient. If the device seeps or creeps from its intended position prior to setting and creates incomplete void or gap filling, possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.
Distribution: Nationwide distribution to CA, FL, IL, IN, KY, MN, MO, MT, OH, PA, TX, VA, WA.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2390-2020, Z-2389-2020, Z-2391-2020

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 mi
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
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 mi

Terminated Class II Medical devices

Recall started: 26 March 2020
Terminated: 26 March 2021
Reason: Nonconforming product; length of the product measured shorter than the labeled length.
Distribution: US Nationwide distribution in the states of CA and MI.
Initiated: Voluntary: Firm initiated
Recall number: Z-1941-2020

VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628

Terminated Class II Medical devices

Recall started: 27 September 2018
Terminated: 16 September 2020
Reason: The Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two absorbable collagen sponges (ACS), but should only contain one ACS.
Distribution: US
Initiated: Voluntary: Firm initiated
Recall number: Z-0440-2019

INFUSE Bone Graft X SMALL KIT REF 7510100

Terminated Class II Medical devices

Recall started: 9 July 2018
Terminated: 7 May 2021
Reason: This lot has incorrectly been laser marked both on the screw head itself as well as the data carrier tag attached to the screw. The description on face two of the screw head and on the data carrier tag both incorrectly indicate a 5.5 mm diameter screw when the actual screw diameter aligns with 5.0 diameter screw size requirements.
Distribution: US
Initiated: Voluntary: Firm initiated
Recall number: Z-2603-2018

Medtronic CD HORIZON Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, or sacral spine.MULTI-AXIAL SCREW FOR 5.5/6.0MM RODS, RE

Terminated Class II Medical devices

Recall started: 23 March 2018
Terminated: 25 July 2021
Reason: Slot screw had an overall length of 15mm, but per the specification, the screw should have an overall length of approximately 17mm.
Distribution: Worldwide Distribution - US Nationwide in the states of GA, CT, LA, MD, WY, IN, MD, FL, and France
Initiated: Voluntary: Firm initiated
Recall number: Z-1750-2018

Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Size 4.5mm x 15mm Product Appliance, fixation, spinal intervertebral body

Terminated Class II Medical devices

Recall started: 13 March 2018
Terminated: 2 November 2020
Reason: The firm received complaints of drill bits breaking during use with the Prestige LP(TM) Cervical Disc System. Subsequent investigation demonstrated the interaction of the drill guide and the drill bit may lead to drill bit breakage.
Distribution: US Nationwide Distribution
Initiated: Voluntary: Firm initiated
Recall number: Z-1641-2018

Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL GUIDES: a) REF 6975205, 5mm b) REF 6975206, 6mm c) REF 6975207, 7mm Product Usage: The PRESTIGE LP reusable instruments are inten

Terminated Class II Medical devices

Recall started: 22 December 2017
Terminated: 31 July 2018
Reason: Medtronic has discovered the product lot in question was noted as having a longer drill tip extension than what is indicated on the print specification.
Distribution: MN, NC
Initiated: Voluntary: Firm initiated
Recall number: Z-0566-2018

Medtronic ANGLED DRILL, REF 6630902, QTY: 1 EA Rx only

Terminated Class II Medical devices

Recall started: 6 December 2017
Terminated: 4 November 2019
Reason: Medtronic has discovered the directional arrow at the proximal end of the instrument may not correctly align with the cut out opening on the distal end of the instrument.
Distribution: US. Austria, Belgium, Bulgaria, Canada, France, Germany, Italy, Lebanon, Luxembourg, Portugal, South Africa, US
Initiated: Voluntary: Firm initiated
Recall number: Z-0352-2018

Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.