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GEN2

SURGIX MEDICAL LLC · Model G2E901173 · UDI-DI 00840343723262

HTR Prescription
9
510(k) clearances
285
Adverse events (1 deaths)
2
Recalls
265
Facilities

Description

Doyen Rib Rasp, adult, left, 6.75 inches (17cm)

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.