American Medical Systems

Lot/serial number 372128/001-030 (domestic) and 374329/001-032 (international)

General and Plastic Surgery Devices

2

Yes

The product was shipped to consignees in Connecticut, Indiana, MIchigan, North Carolina, Ohio, and Texas in the United States and to Belgium.

Monarc Subfascial Hammock With Tensioning Suture, Product Number 72403830/1

Lots 431803 & 436666

Obstetrical and Gynecological Devices

3

No

Nationwide. AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NJ, NM, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI

her option Cryoablation Therapy Disposable Probe, Model CU-1. Sterile. Manufactured at: American Medical Systems, Inc., 10700 Bren Road West, Minnetonka, MN 55343 USA. The Her Option Cryoablation Therapy System consists of a Console, a Cryoprobe and a Disposable Probe.

Lot # 472642

Gastroenterology-Urology Devices

3

Yes

Worldwide, including USA, Canada and England.

AMS 700 Ultrex Preconnected penile Prosthesis with InhibiZone, Product length 18 cm, product number 72403924. Penoscrotal Approach - with InhibiZone, 8 Extenders, one pair each .5cm, 1cm, 2cm 3cm; 1 Tactile Pump, 2 Cylinders.

Lot # 475222

Gastroenterology-Urology Devices

3

Yes

Worldwide, including USA, Canada and England.

AMS 700 CX MS Pump IZ Preconnected penile Prosthesis, product length 18 cm, product number 72404232. Penoscrotal Approach - with InhibiZone, 1 MS Pump, 2 Cylinders.

Lot # 475485

Gastroenterology-Urology Devices

3

Yes

Worldwide, including USA, Canada and England.

AMS 700 CX Preconnected penile Prosthesis with InhibiZone, product length 18 cm, product number 72402987. Penoscrotal Approach - with InhibiZone, 8 Extenders, one pair each .5cm, 1cm, 2cm 3cm; 1 Pump, 2 Cylinders.