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Medtronic Resuable Instruments
MEDTRONIC SOFAMOR DANEK, INC. · Model X0416060 · UDI-DI 00643169838239
HTX
Prescription
5
510(k) clearances
618
Adverse events (2 deaths)
7
Recalls
330
Facilities
Description
EJECTOR X0416060 BYNT CRVD KRRSN 1MM/90
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-03 | Sklar Instruments | Reports of various packaging issues that may result in a breach of the sterile barrier. |
| 2017-05-25 | Exactech, 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- |
| 2017-05-25 | Exactech, 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- |
| 2017-05-25 | Exactech, 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- |
| 2017-05-25 | Exactech, 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- |
| 2017-05-25 | Exactech, 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- |
| 2017-05-25 | Exactech, 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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Get your free API keyRead the docsData 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.