Regulatory Record: Medtronic Sofamor Danek USA Inc

FDA action counts

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Medtronic Sofamor Danek USA Inc has 35 separate FDA recalls on file, more than a single isolated recall event. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ does not independently verify FDA's underlying findings; this page summarizes what FDA has published and links back to the original FDA source for each event. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Enforcement history

On 2025-12-03, Argus HQ recorded an FDA recall for Medtronic Sofamor Danek USA Inc, rated "high" severity in Argus HQ's classification: Medtronic Sofamor Danek USA Inc — Class II recall: Catalyft PL & PL40 Expandable Interbody System labeled as follows with correspon…. On 2023-11-01, Argus HQ recorded an FDA recall for Medtronic Sofamor Danek USA Inc, rated "high" severity in Argus HQ's classification: Medtronic Sofamor Danek USA Inc — Class II recall: Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T431…. On 2023-11-01, Argus HQ recorded an FDA recall for Medtronic Sofamor Danek USA Inc, rated "high" severity in Argus HQ's classification: Medtronic Sofamor Danek USA Inc — Class II recall: Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T4…. On 2023-11-01, Argus HQ recorded an FDA recall for Medtronic Sofamor Danek USA Inc, rated "high" severity in Argus HQ's classification: Medtronic Sofamor Danek USA Inc — Class II recall: Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; Demineralized Bo…. On 2023-11-01, Argus HQ recorded an FDA recall for Medtronic Sofamor Danek USA Inc, rated "high" severity in Argus HQ's classification: Medtronic Sofamor Danek USA Inc — Class II recall: Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix. On 2023-11-01, Argus HQ recorded an FDA recall for Medtronic Sofamor Danek USA Inc, rated "high" severity in Argus HQ's classification: Medtronic Sofamor Danek USA Inc — Class II recall: Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matr…. On 2023-11-01, Argus HQ recorded an FDA recall for Medtronic Sofamor Danek USA Inc, rated "high" severity in Argus HQ's classification: Medtronic Sofamor Danek USA Inc — Class II recall: Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix. On 2023-11-01, Argus HQ recorded an FDA recall for Medtronic Sofamor Danek USA Inc, rated "high" severity in Argus HQ's classification: Medtronic Sofamor Danek USA Inc — Class II recall: Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Deminera…. On 2023-09-20, Argus HQ recorded an FDA recall for Medtronic Sofamor Danek USA Inc, rated "high" severity in Argus HQ's classification: Medtronic Sofamor Danek USA Inc — Class II recall: Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demin…. On 2023-08-16, Argus HQ recorded an FDA recall for Medtronic Sofamor Danek USA Inc, rated "high" severity in Argus HQ's classification: Medtronic Sofamor Danek USA, Inc — Class II recall: CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K. On 2023-07-19, Argus HQ recorded an FDA recall for Medtronic Sofamor Danek USA Inc, rated "high" severity in Argus HQ's classification: Medtronic Sofamor Danek USA Inc — Class II recall: Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF…. On 2023-07-19, Argus HQ recorded an FDA recall for Medtronic Sofamor Danek USA Inc, rated "high" severity in Argus HQ's classification: Medtronic Sofamor Danek USA Inc — Class II recall: Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF….

Frequently asked questions

Has Medtronic Sofamor Danek USA Inc had product recalls?

Yes, 35 recalls on file. See the full history below for each one.

Is this FDA enforcement data for Medtronic Sofamor Danek USA Inc official?

Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.

How many FDA actions has Medtronic Sofamor Danek USA Inc had?

Argus HQ has recorded 35 FDA events for Medtronic Sofamor Danek USA Inc: 0 warning letters, 35 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

What is the most recent FDA action against Medtronic Sofamor Danek USA Inc?

The most recent FDA event Argus HQ has on file for Medtronic Sofamor Danek USA Inc is dated 2025-12-03, with a severity rating of "high" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Related enforcement actions

• Medtronic Sofamor Danek USA Inc — Class II recall: Catalyft PL & PL40 Expandable Interbody System labeled as follows with correspon… →
• Medtronic Sofamor Danek USA Inc — Class II recall: Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Deminera… →
• Medtronic Sofamor Danek USA Inc — Class II recall: Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix →
• Medtronic Sofamor Danek USA Inc — Class II recall: Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matr… →
• Medtronic Sofamor Danek USA Inc — Class II recall: Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix →
• Medtronic Sofamor Danek USA Inc — Class II recall: Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; Demineralized Bo… →
• Medtronic Sofamor Danek USA Inc — Class II recall: Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T4… →
• Medtronic Sofamor Danek USA Inc — Class II recall: Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T431… →
• Medtronic Sofamor Danek USA Inc — Class II recall: Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demin… →
• Medtronic Sofamor Danek USA, Inc — Class II recall: CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K →

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