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Integra® Jarit®

INTEGRA LIFESCIENCES PRODUCTION CORPORATION · Model 630111 · UDI-DI 10381780152002

KNF Prescription
10
510(k) clearances
404
Adverse events
5
Recalls
50
Facilities

Description

Integra® Jarit® Strong Forceps, 9-1/2" working length, Roto-Lok™, Monopolar, double action, insulated, 3.5mm

Recalls

DateFirmReason
2013-02-12Integra LifeSciences Corp.Addendum to the Instructions for Use. The addendum emphasizes the warnings and precautions already contained in the device's IFU and also provides additional warnings and precautio
2012-05-23Integra LimitedThe Integra(TM) Jarit(R) Take-Apart Laparoscopic Instrument shafts were released with internal component out of specification.
2009-12-01LINA Medical ApSPotential for the LiNA Loop to break during operating procedure.
2009-12-01LINA Medical ApSPotential for the LiNA Loop to break during operating procedure.
2009-12-01LINA Medical ApSPotential for the LiNA Loop to break during operating procedure.

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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.