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Benefix™ Interspinous Fixation System

CG MedTech Co.,Ltd. · Model ISS1001 · UDI-DI 08800015955720

HWN Prescription
4
510(k) clearances
822
Adverse events
9
Recalls
167
Facilities

Recalls

DateFirmReason
2010-02-16Zimmer Inc.The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential
2010-02-16Zimmer Inc.The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential
2010-02-16Zimmer Inc.The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential
2010-02-16Zimmer Inc.The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential
2010-02-16Zimmer Inc.The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential
2010-02-16Zimmer Inc.The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential
2010-02-16Zimmer Inc.The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential
2010-02-16Zimmer Inc.The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential
2010-02-16Zimmer Inc.The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential

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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.