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Tatum Surgical-Osteotome Kit

Suncoast Dental, Inc · Model Tatum Universal Offset Osteotome Kit · UDI-DI 00083208002229

EMM Prescription

510(k) clearances

Adverse events

Recalls

132

Facilities

Description

Tatum Universal Offset Osteotome Kit designed for use in bone expansion: Includes 24 instruments and 2 Autoclaveable cassettes: Bone Scalpels (Blue) - BS4.0, 5.0 & 6.0, Bone Blades (Green) - BB5.5, 7.5, & 10.0, "D" Shape (Black) - D1-4.0, D2-5.5, D3-7.5, & D4-10.0, Round Tapered (White) - RT2.0, 3.0, 4.0, & 5.0 Round Parallel Pointed (Yellow) - RP3.0, 3.5, 4.0, 4.5, & 5.0, Round Parallel Blunt (Red) - RB3.0, 3.5, 4.0, 4.5, & 5.0

Recalls

Date	Firm	Reason
2008-04-16	Biomet Microfixation, Inc.	The working tips of the Stella Osteotomes are thicker than specification.

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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.