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Rongeur, Conchotome, for decalcification 30cm 3mm 30° upwards

Geister Medizintechnik GmbH · Model 34-7451 · UDI-DI 04057034120255

HTX Prescription
5
510(k) clearances
623
Adverse events (2 deaths)
7
Recalls
330
Facilities

Description

Rongeur, Conchotome, for decalcification 30cm 3mm 30° upwards ValveGate™

Recalls

DateFirmReason
2024-12-03Sklar InstrumentsReports of various packaging issues that may result in a breach of the sterile barrier.
2017-05-25Exactech, Inc.Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the surgeon should ream on-
2017-05-25Exactech, Inc.Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the surgeon should ream on-
2017-05-25Exactech, Inc.Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the surgeon should ream on-
2017-05-25Exactech, Inc.Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the surgeon should ream on-
2017-05-25Exactech, Inc.Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the surgeon should ream on-
2017-05-25Exactech, Inc.Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the surgeon should ream on-

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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.