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TITAN™ DOUBLE WIRE

JACE MEDICAL, LLC · Model 132.640.22 · UDI-DI 00853190008963

GAO Prescription
4
510(k) clearances
601
Adverse events (10 deaths)
1
Recalls
18
Facilities

Description

MONOFILAMENT 316 LVM STAINLESS STEEL SUTURE, BE3 NEEDLE, 49MM, USP 6, 14", 2 PK

Recalls

DateFirmReason
2015-02-11EXP Pharmaceutical Services CorpEXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were re

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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.