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AESCULAP

Aesculap AG · Model PO114R · UDI-DI 04038653260409

KNF Prescription
10
510(k) clearances
407
Adverse events
5
Recalls
50
Facilities

Description

BABCOCK ADTEC MONOPOLAR Organ Grasping Forceps, complete instrument, straight, (310 mm), diam. 10 mm, serrated (cross), single action, consisting of PM974R, PO620R, PO959R, reusable

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.