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ATRAMAT

Internacional Farmacéutica, S.A. de C.V. · Model POLYESTER · UDI-DI 07500142008306

GAS
1
510(k) clearances
825
Adverse events (9 deaths)
1
Recalls
43
Facilities

Description

ATRAMAT POLYESTER SURGICAL SUTURE GREEN USP 4-0 EP 1,5, 75 CM NEEDLE CE-16 REVERSE CUTTING 16 MM 3/8 CIRCLE

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.

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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.