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Bone Shark®

Tarca LLC · Model BS-101 · UDI-DI 00850048404090

LYS
4
510(k) clearances
1,275
Adverse events
1
Recalls
85
Facilities

Description

Bone Shark® Sterile Disposable Bone Mill

Recalls

DateFirmReason
2006-10-20Medtronic Sofamor Danek USA IncMetal bone fragmentor was causing metal shavings to be released into the resultant fragmented tissue during use.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.