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AESCULAP
Aesculap AG · Model PO107R · UDI-DI 04038653260331
KNF
Prescription
10
510(k) clearances
404
Adverse events
5
Recalls
50
Facilities
Description
ADTEC MONOPOLAR Grasping Forceps, complete instrument, straight, (310 mm), diam. 5 mm, serrated (coarse), pike-mouth, with reservoirin the jaws, double action, consisting of PM973R, PO613R, PO959R, reusable
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2013-02-12 | Integra 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 |
| 2012-05-23 | Integra Limited | The Integra(TM) Jarit(R) Take-Apart Laparoscopic Instrument shafts were released with internal component out of specification. |
| 2009-12-01 | LINA Medical ApS | Potential for the LiNA Loop to break during operating procedure. |
| 2009-12-01 | LINA Medical ApS | Potential for the LiNA Loop to break during operating procedure. |
| 2009-12-01 | LINA Medical ApS | Potential for the LiNA Loop to break during operating procedure. |
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Get your free API keyRead the docsData 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.