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Quinelato

Schobell Industrial Ltda · Model QO.372.30 · UDI-DI 07898506848522

KDG Prescription
10
510(k) clearances
16
Adverse events
14
Recalls
87
Facilities

Description

Lambotte Osteotome 24cm straight 30mm

Recalls

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