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ATRAMAT

Internacional Farmacéutica, S.A. de C.V. · Model POLIESTER · UDI-DI 07500142003172

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

Description

ATRAMAT POLYESTER SURGICAL SUTURE GREEN USP 5-0 EP 1, 45 CM DOUBLE NEEDLE EA-8 PREMIUM SPATULA 8 MM 1/4 CIRCLE POLIESTER USP 5-0, 45 CM DOBLE AGUJA EA-8 ESPATULADA PREMIUM 8 MM 1/4 CIRCULO

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.