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Blustone Synergy Lumbar PLIF Pusher (Basalt)

BLUSTONE SYNERGY, LLC · Model 9200-PP01 · UDI-DI 00810482031412

HXO Prescription
3
510(k) clearances
59
Adverse events
1
Recalls
75
Facilities

Description

The BluStone Synergy Basalt System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899. The Basalt PLIF Pusher is 8.35 inches long.

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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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.