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MEGA SPINE SYSTEM

BK MEDITECH CO.,LTD. · Model 61740 · UDI-DI 08809763500909

HXO Prescription
3
510(k) clearances
58
Adverse events
1
Recalls
75
Facilities

Description

Long-Arm Reduction Introducer

Recalls

DateFirmReason
2010-08-02Biomet, Inc.The firm has received four complaints that the closed knot pusher is missing a radius which contributes to sutures being cut during surgery.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.