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SOLITAIRE CERVICAL SPACER SYSTEM

Highridge Medical, LLC · Model 14-533782 · UDI-DI 03662663172196

HTR
9
510(k) clearances
281
Adverse events (1 deaths)
2
Recalls
265
Facilities

Description

ADI LEFT ANGLE RASP 10MM

Recalls

DateFirmReason
2013-05-03Surgical Instrument Service And Savings, Inc.The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
2008-08-08Sterilmed IncSteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility e

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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.