ProductGuru Recalls

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Medtronic Sofamor Danek USA Inc: official recall notices

9 official recall or safety notices published on this site name Medtronic Sofamor Danek USA Inc, dated between 2023-06-06 and 2026-08-12. They were issued by 1 authority: US FDA — Medical Devices (9).

Countries where the notices were issued: United States (9).

Name as written in the notices: Medtronic Sofamor Danek USA Inc. This is the brand or the responsible company as each authority recorded it. A recall shows a safety system working; it is not a verdict on a brand. Follow the official notice for each product.

What this page counts: the notices published as pages on product-guru.org, over every date (this site publishes a selection of the notices in the ProductGuru index). The brand scorecards count every indexed notice in a rolling 24-month window instead, so their totals differ from this page.

Notices by year

YearNotices
20262
20237

Notices by authority

AuthorityNotices
US FDA — Medical Devices9

All notices

DateAuthorityProductHazard (as classified)
2026-08-12US FDA — Medical DevicesGrafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a de—
2026-08-12US FDA — Medical DevicesGrafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a d—
2023-09-26US FDA — Medical DevicesGrafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix—
2023-09-26US FDA — Medical DevicesGrafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix—
2023-09-26US FDA — Medical DevicesGrafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; Demineralized Bone Matrix—
2023-09-26US FDA — Medical DevicesGrafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix—
2023-09-26US FDA — Medical DevicesGrafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f) T43110, g) T43110IN—
2023-06-06US FDA — Medical DevicesMedtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage, REF SPS03188, spinal implant ki—
2023-06-06US FDA — Medical DevicesMedtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027725, spinal implant—

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