Medtronic Sofamor Danek USA recalls

Medtronic Sofamor Danek USA has 77 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 3 Dec 2025. 27 are still ongoing. 1 was reported in the last 12 months.

Total recalls77since 2012

Last 12 months1reported

Class I00% of total

Ongoing27latest 3 Dec 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 1 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 77 100%Class III 0 0%

Why medtronic sofamor danek usa is recalled

Product types

By year

202511%
20232634%
202156%
20201013%
201868%
201768%
2016810%
201523%
201423%
2013810%

Ongoing medtronic sofamor danek usa recalls

27 active

Reported	Class	Recall	Company	Reason	Where
3 Dec 2025Device	CLASS II	Catalyft PL & PL40 Expandable Interbody System labeled as recalled	Medtronic Sofamor Danek USA	Other	Nationwide
1 Nov 2023Device	CLASS II	Grafton DBM Crunch recalled by Medtronic Sofamor Danek USA	Medtronic Sofamor Danek USA	Processing Deviation	TN
1 Nov 2023Device	CLASS II	Grafton DBM Matrix Strips recalled by Medtronic Sofamor Danek USA	Medtronic Sofamor Danek USA	Processing Deviation	TN
1 Nov 2023Device	CLASS II	Grafton DBM Putty recalled by Medtronic Sofamor Danek USA	Medtronic Sofamor Danek USA	Processing Deviation	TN
1 Nov 2023Device	CLASS II	Grafton Plus DBM Paste recalled by Medtronic Sofamor Danek USA	Medtronic Sofamor Danek USA	Processing Deviation	TN
1 Nov 2023Device	CLASS II	Grafton DBM Orthoblend recalled by Medtronic Sofamor Danek USA	Medtronic Sofamor Danek USA	Processing Deviation	TN

All medtronic sofamor danek usa recalls, newest first

77 total

Reported	Class	Recall	Company	Reason	Where
3 Dec 2025Device	CLASS II	Catalyft PL & PL40 Expandable Interbody System labeled as recalled	Medtronic Sofamor Danek USA	Other	Nationwide
1 Nov 2023Device	CLASS II	Grafton DBM Crunch recalled by Medtronic Sofamor Danek USA	Medtronic Sofamor Danek USA	Processing Deviation	TN
1 Nov 2023Device	CLASS II	Grafton DBM Matrix Strips recalled by Medtronic Sofamor Danek USA	Medtronic Sofamor Danek USA	Processing Deviation	TN
1 Nov 2023Device	CLASS II	Grafton DBM Putty recalled by Medtronic Sofamor Danek USA	Medtronic Sofamor Danek USA	Processing Deviation	TN
1 Nov 2023Device	CLASS II	Grafton Plus DBM Paste recalled by Medtronic Sofamor Danek USA	Medtronic Sofamor Danek USA	Processing Deviation	TN
1 Nov 2023Device	CLASS II	Grafton DBM Orthoblend recalled by Medtronic Sofamor Danek USA	Medtronic Sofamor Danek USA	Processing Deviation	TN
1 Nov 2023Device	CLASS II	Grafton DMB Matrix recalled by Medtronic Sofamor Danek USA	Medtronic Sofamor Danek USA	Processing Deviation	TN
1 Nov 2023Device	CLASS II	Grafton DBM (Flex) recalled by Medtronic Sofamor Danek USA	Medtronic Sofamor Danek USA	Processing Deviation	TN
20 Sep 2023Device	CLASS II	Magnifuse Bone Graft, Large, Size recalled	Medtronic Sofamor Danek USA	Packaging Defects	Nationwide
16 Aug 2023Device	CLASS II	CD Horizon Spinal System Solera Awl Tip Tap recalled	Medtronic Sofamor Danek USA	Other	Nationwide
19 Jul 2023Device	CLASS II	Medtronic Catalyft LS Expandable Interbody System recalled	Medtronic Sofamor Danek USA	Potency & Assay	Nationwide
19 Jul 2023Device	CLASS II	Medtronic Catalyft LS Expandable Interbody System recalled	Medtronic Sofamor Danek USA	Potency & Assay	Nationwide
19 Jul 2023Device	CLASS II	Medtronic Catalyft LS Expandable Interbody System recalled	Medtronic Sofamor Danek USA	Potency & Assay	Nationwide
19 Jul 2023Device	CLASS II	Medtronic Catalyft LS Expandable Interbody System recalled	Medtronic Sofamor Danek USA	Potency & Assay	Nationwide
19 Jul 2023Device	CLASS II	Medtronic Catalyft LS Expandable Interbody System recalled	Medtronic Sofamor Danek USA	Potency & Assay	Nationwide
19 Jul 2023Device	CLASS II	Medtronic Catalyft LS Expandable Interbody System recalled	Medtronic Sofamor Danek USA	Potency & Assay	Nationwide
19 Jul 2023Device	CLASS II	Medtronic Catalyft LS Expandable Interbody System Implant recalled	Medtronic Sofamor Danek USA	Potency & Assay	Nationwide
17 May 2023Device	CLASS II	Distractor Rack recalled by Medtronic Sofamor Danek USA	Medtronic Sofamor Danek USA	Packaging Defects	CT, IN, NE
26 Apr 2023Device	CLASS II	Infinity Occipitocervical Upper Thoracic System recalled	Medtronic Sofamor Danek USA	Other	Nationwide
26 Apr 2023Device	CLASS II	Infinity Occipitocervical Upper Thoracic System recalled	Medtronic Sofamor Danek USA	Other	Nationwide
26 Apr 2023Device	CLASS II	Infinity Occipitocervical Upper Thoracic System recalled	Medtronic Sofamor Danek USA	Other	Nationwide
26 Apr 2023Device	CLASS II	Infinity Occipitocervical Upper Thoracic System recalled	Medtronic Sofamor Danek USA	Other	Nationwide
26 Apr 2023Device	CLASS II	Infinity Occipitocervical Upper Thoracic System recalled	Medtronic Sofamor Danek USA	Other	Nationwide
12 Apr 2023Device	CLASS II	Medtronic Grafton Flex: a) Dbm S42090 Grafton X Flex recalled	Medtronic Sofamor Danek USA	Sterility	Nationwide
12 Apr 2023Device	CLASS II	Medtronic Accelerate Grafton Dbf a) Accelerate BG Set recalled	Medtronic Sofamor Danek USA	Sterility	Nationwide
12 Apr 2023Device	CLASS II	Medtronic Xpanse Bone Insert: a) Dbm T600106 Xpanse Small-c recalled	Medtronic Sofamor Danek USA	Sterility	Nationwide
12 Apr 2023Device	CLASS II	Medtronic Grafton Crunch a) Dbm S44105 Grafton 5CC Crunch recalled	Medtronic Sofamor Danek USA	Sterility	Nationwide
20 Oct 2021Device	CLASS II	Endoskeleton" TAS Interbody System recalled	Medtronic Sofamor Danek USA	Device Malfunction	14 states
20 Oct 2021Device	CLASS II	Endoskeleton" TCS Interbody System recalled	Medtronic Sofamor Danek USA	Device Malfunction	14 states
16 Jun 2021Device	CLASS II	Braive Growth Modulation System Break-Off Set Screws recalled	Medtronic Sofamor Danek USA	Device Malfunction	TN

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.