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GEN2
SURGIX MEDICAL LLC · Model G2N99380 · UDI-DI 00840343704063
HTX
Prescription
5
510(k) clearances
618
Adverse events (2 deaths)
7
Recalls
329
Facilities
Description
LEKSELL RONGEUR, 5MM JAW, LIGHT CURVE, 36CM
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.