The trocar KII access systems are indicated in laparoscopic interventions of general, abdominal, gynecological and thoracic minimally invasive surgery, with the purpose of establishing an insertion path or achieving access through tissue planes and / or potential spaces for endoscopic instruments. All components are made of latex-free materials. The trocar access systems are sterile and disposable devices for use in a single patient. Optical trocar access systems use an optical element to visualize the tissue layers during insertion; however, they can be used without visualization for primary or secondary inserts.

CA090 with expiration date prior to March 18, 2019, lots 1190181 through 1265006.

It is indicated for ligating vessels that, in the opinion of the surgeon, require a medium or large size ligature clip.

Model: , Affected: CTR14 Kii 5x55mm Optical Z-Thread Dual Pack. Lots 1269694, 1275188, 1279039, 1283226, and 1287785

Model: CA090, Affected: All lots and batches

Model: Model: CD004, Affected: 75 lots

Model: Models: APP-C4130, APP-C4130-S, Affected: Lot Numbers: 1145945, 1147900, 1148677, 1154637, 1159491, 1162504, 1168638, 1171631

Model: Model Numbers: A4403, A4405, A4406, A4407, A4752, A4F00, A4F01, A4F02, A4F03, A4F04, A4F05, A4F06, A4F07, A4F08., Affected: 48 lots

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CTB14 (lots 1275207, 1279542, 1283892 and 1288910) CTB23 (lots 1269692, 1271037, 1282163 and 1288759) CTR14 (lots 1269694, 1275188, 1279039, 1283226, and 1287785)

General and Plastic Surgery Devices

2

No

US and worldwide: Australia, Finland, France, United Kingdom

Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and || Kii 5x55mm Optical Z-Thread Dual Pack (CTR14) trocars.

Model Number: EB040  Lot Numbers: 1243964, 1243975, 1244125  Model Number: EB040+ Lot Numbers: 1245512, 1245513, 1246241, 1246508, 1247079, 1247566, 1248102, 1249264

General and Plastic Surgery Devices

2

No

Worldwide Distribution - U.S Nationwide in the states of:FL, GA, NV. and countries of: France, Netherlands, Spain, and United Kingdom.

Voyant Open Fusion Device || Models: EB040 and EB040+ || Product Usage: The Applied Voyant Open Fusion Device is designed for use with the Voyant Electrosurgical Generator. The device is an advanced bipolar instrument that uses RF energy, provided by the generator, to seal vessels up to and including 5mm (EB040+) or 7mm (EB040) in diameter. The device may also be used to seal tissue bundles that can be captured in the device jaws. The system delivers the energy required to fuse the tissue between the jaws of the device by monitoring voltage and current throughout the seal cycle. The device also features a useractuated blade for the transection of sealed tissue.