Medtronic Sofamor Danek USA Inc recalls
Every recall we track for Medtronic Sofamor Danek USA Inc — 58 in all, from 2017–2026 — plus the complaints and injury reports the public filed about them. 1 is rated “stop using now”.
Recalls per year, by danger level
Recalls from Medtronic Sofamor Danek USA Inc peaked in 2023 (33); 58 since 2017. 2% rated “stop using now”.
All FDA recall records for Medtronic Sofamor Danek USA Inc since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 2 | 0 | 2 |
| 2018 | 0 | 1 | 2 | 1 | 4 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 3 | 7 | 0 | 10 |
| 2021 | 0 | 0 | 6 | 0 | 6 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 3 | 28 | 2 | 33 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 1 | 0 | 1 |
| 2026 (to date) | 1 | 0 | 0 | 1 | 2 |
Most common reasons for Medtronic Sofamor Danek USA Inc recalls
What to do if you have a recalled Medtronic Sofamor Danek USA Inc product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Medtronic Sofamor Danek USA Inc recalls
21 shown- Stop using nowMedical device
Medtronic Sofamor Danek USA Inc recalls Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a
Medtronic Sofamor Danek recalls 20 units of Grafton DBM and Grafton Plus DBM products due to potential Clostridium butyricum infection risk from donor tissue. Stop using immediately if you have the affected serial numbers.
Medtronic Sofamor DanekAug 12, 2026 - Lower riskMedical device
Medtronic Sofamor Danek USA Inc recalls Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073
Medtronic 6069073
MedtronicSep 16, 2025 - Lower riskMedical device
Medtronic Sofamor Danek USA Inc recalls Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix
Medtronic Sofamor Danek recalls specific Grafton DBM (Flex) implants due to potential non-conformances in the Tyvek pouch from improper inspection during manufacturing.
Medtronic Sofamor DanekSep 26, 2023 - Lower riskMedical device
Medtronic Sofamor Danek USA Inc recalls Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile.
Medtronic Sofamor Danek recalls Magnifuse Bone Graft (14mm x 25mm) due to incorrect labeling indicating wrong size. Affected units have specific serial numbers and expiration date 2/15/2025.
Medtronic Sofamor DanekJul 31, 2023 - UnratedMedical device
Medtronic Sofamor Danek USA, Inc recalls CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
Medtronic Sofamor Danek USA recalls Solera Awl Tip Tap (REF NAV2006K) due to incorrect laser marking. Affected units include specific batch numbers and lot numbers from the SOLERA TAPS Kit.
Medtronic Sofamor Dan: a short, human brand name for headings (e.g.Jul 12, 2023 - Lower riskMedical device
Medtronic Sofamor Danek USA Inc recalls Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage, REF SPS03188, spinal implant
Medtronic recalls specific spinal implant kits (REF SPS03188) due to possible incorrect device geometries that could affect spinal fusion surgery. Affected kits include lot numbers 0001-0029.
MedtronicJun 6, 2023 - Use cautionMedical device
Medtronic Sofamor Danek USA Inc recalls INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm, REF 3604024; for immobilization
Medtronic Sofamor Danek recalls Infinity Multi-Axial Screws (4.0mm x 24mm) due to weak grip from incorrect titanium. Affected units have batch H5802983. Contact for remedy.
Medtronic Sofamor DanekFeb 16, 2023 - Lower riskMedical device
Medtronic Sofamor Danek USA Inc recalls Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; b) GRAFTON T50306 DBF INJECT 6CC, REF
Medtronic Sofamor Danek recalls Grafton DBF Inject 3CC and 6CC products with potential packaging non-conformances that could breach the sterile barrier. Affected items have specific serial numbers listed in the recall notice.
Medtronic Sofamor DanekFeb 8, 2023 - Lower riskMedical device
Medtronic Sofamor Danek USA Inc recalls Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in
Medtronic Sofamor Danek recalls Distractor Rack REF 5598007 with incorrect gear width that may cause operation issues during spinal surgery. Affected units include specific lot numbers and loaner kits.
Medtronic Sofamor DanekNov 19, 2021 - Lower riskMedical device
Medtronic Sofamor Danek USA Inc recalls Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm
Medtronic Sofamor Danek recalls Endoskeleton TCS Interbody System with Titan nanoLOCK Surface Technology due to possible mismatch between implant engraving and pouch labels. Affected units may require verification of labels before use.
Medtronic Sofamor DanekSep 2, 2021 - Lower riskMedical device
Medtronic Sofamor Danek USA, Inc recalls Braive Growth Modulation System Break-Off Set Screws - Product Usage: intended to limit further progression of the
Medtronic Sofamor Danek recalls Braive Growth Modulation System Break-Off Set Screws due to a thread profile defect from manufacturing. Affected models CT20L012 and CT20L020 sold until December 2028.
Medtronic Sofamor DanekApr 27, 2021 - Lower riskMedical device
Medtronic Sofamor Danek USA, Inc recalls Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Large, 8 mm, Product Number
Medtronic recalls Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology due to shelf box mislabeling. This may cause confusion about device size. No immediate action needed.
Medtr: a short, human brand name for headings (e.g.Mar 17, 2021 - Lower riskMedical device
Medtronic Sofamor Danek USA Inc recalls Accurian RF Ablation, Cannula pk, Accurian, 150mm, 20G, 10mm, CS Product Number: AC0012 GTIN / UPN: 20763000153629 -
Medtronic Sofamor Danek recalls Accurian RF Ablation Cannula due to insertion difficulty caused by probe catching on cannula hub lip. Affected units have specific product numbers and lot numbers.
Medtronic Sofamor DanekJun 8, 2020 - Lower riskMedical device
Medtronic Sofamor Danek USA Inc recalls Medtronic Bone Void Filler, Small - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone
Medtronic recalls small bone void filler that may not set correctly, leading to longer surgery and potential bone healing issues. Affected units have specific product numbers and lot numbers.
MedtronicApr 24, 2020 - Lower riskMedical device
Medtronic Sofamor Danek USA Inc recalls VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628
Medtronic Sofamor Danek recalls Vertex Select Multi Axial Screws (4.0 x 38mm) with shorter length than labeled. Affected units may not fit properly in spinal surgery.
Medtronic Sofamor DanekMar 26, 2020 - Lower riskMedical device
Medtronic Sofamor Danek USA Inc recalls INFUSE Bone Graft X SMALL KIT REF 7510100
Medtronic Sofamor Danek recalls INFUSE Bone Graft X SMALL KIT REF 7510100 with lot M111806AAA due to potential extra collagen sponges. Affected patients should contact for guidance.
Medtronic Sofamor DanekSep 27, 2018 - UnratedMedical device
Medtronic Sofamor Danek USA Inc recalls Medtronic CD HORIZON Spinal System is intended to help provide immobilization and stabilization of spinal segments as
Medtronic recalls CD HORIZON Spinal System screws with incorrect 5.5mm marking (actual 5.0mm) that could lead to improper spinal fusion. Affected units sold in 2023 with specific lot numbers.
MedtronicJul 9, 2018 - Lower riskMedical device
Medtronic Sofamor Danek USA Inc recalls Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Size 4.5mm x 15mm Product Appliance,
Medtronic recalls a specific slot screw in spinal implants due to incorrect length. This mismatch could affect surgical stability. Affected units have a 15mm length instead of the required 17mm.
MedtronicMar 23, 2018 - Use cautionMedical device
Medtronic Sofamor Danek USA Inc recalls Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL GUIDES: a) REF 6975205, 5mm b) REF
Medtronic recalls cervical disc surgery instruments with drill guides that may break during use, causing potential complications. Affected models include REF 6975205, 6975206, and 6975207 with specific lot numbers.
MedtronicMar 13, 2018 - Lower riskMedical device
Medtronic Sofamor Danek USA Inc recalls Medtronic ANGLED DRILL, REF 6630902, QTY: 1 EA Rx only
Medtronic recalls a single angled drill (REF 6630902) due to a longer drill tip extension than specified, which may cause improper use. Affected units have UDI 00643169363502 and lot number EM17F015.
Medtr: A short, human brand name for headings (e.g.Dec 22, 2017 - Lower riskMedical device
Medtronic Sofamor Danek USA Inc recalls Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R
Medtronic recalls specific size 2 directional bone filler devices due to potential misalignment of the directional arrow, which could lead to improper surgical placement. Affected units have unique lot numbers and are prescription-only.
MedtronicDec 6, 2017
Medtronic Sofamor Danek USA Inc recall questions
How many recalls has Medtronic Sofamor Danek USA Inc had?
58 recalls from Medtronic Sofamor Danek USA Inc are on record with U.S. safety agencies, from 2017–2026.
What is the most recent Medtronic Sofamor Danek USA Inc recall?
Medtronic Sofamor Danek USA Inc recalls Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a, dated Aug 12, 2026. Every Medtronic Sofamor Danek USA Inc recall is listed on this page, newest first.
Why are Medtronic Sofamor Danek USA Inc products recalled?
The most common reasons on record: Engraving on implants may not match what is listed on the pouch labels. (2).
What should I do if I have a recalled Medtronic Sofamor Danek USA Inc product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Medtronic Sofamor Danek USA Inc recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.