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Medtronic Resuable Instruments

MEDTRONIC SOFAMOR DANEK, INC. · Model X0915033 · UDI-DI 00643169672192

KDG Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

CHISEL X0915033 WIDE HEAD 12MM

Recalls

Date	Firm	Reason
2019-01-11	AAP Implantate Ag	There is the potential for the Lambotte chisel to break at the welded piece parts of the chisel body and knocking plate.
2018-03-15	Zimmer GmbH	Product may contain a gap between the handle and metal chisel which can lead to failure to properly disinfect or sterilize between use.
2017-03-30	Smith & Nephew, Inc.	The stability data does not support the product labeled with a 10-year shelf life.
2017-03-30	Smith & Nephew, Inc.	The stability data does not support the product labeled with a 10-year shelf life.
2017-03-30	Smith & Nephew, Inc.	The stability data does not support the product labeled with a 10-year shelf life.
2017-03-30	Smith & Nephew, Inc.	The stability data does not support the product labeled with a 10-year shelf life.
2017-03-30	Smith & Nephew, Inc.	The stability data does not support the product labeled with a 10-year shelf life.
2017-03-30	Smith & Nephew, Inc.	The stability data does not support the product labeled with a 10-year shelf life.
2017-03-30	Smith & Nephew, Inc.	The stability data does not support the product labeled with a 10-year shelf life.
2017-03-30	Smith & Nephew, Inc.	The stability data does not support the product labeled with a 10-year shelf life.

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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.