Devices

Device Recall Zero

Model / Serial
Zero Regular 10-Ct: SKU# 0-70907-20510-5 Master Case: 30070907205106.
Product Classification
Obstetrical and Gynecological Devices
Device Class
2
Implanted device?
No
Distribution
.Nationwide Distribution including the states of AL, AZ, CA, CO, DE, FL, GA, IA, IN, IL, KS, KY, LA, MI, MN, MO.MS, NC, NH, NJ, NY, OH, OR, PA, RI, SC, TN, TX, VA, WI and UT.
Product Description
LifeStyles ZERO 10 uber-thin lubricated latex condoms. Mfd. for Ansell Healthcare Products LLC, Dothan, AL 96303. || A sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections).
Manufacturer
Ansell Healthcare Products LLC
1 Event
- Recall of Device Recall Zero

Manufacturer

Ansell Healthcare Products LLC

Manufacturer Address
Ansell Healthcare Products LLC, 111 Wood Ave S, Suite 210, Iselin NJ 08830-2700
Manufacturer Parent Company (2017)
Ansell Ltd.
Source
USFDA

2 devices with a similar name

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Device Recall Zero tip

Model / Serial
All units.
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide, Argentina, Australia, Belgium, Brazil, Canada, Chile, Denmark, Dominican Republic, Finland, France, Germany, Great Britain, Greece, Hong Kong, Ireland, Italy, Malaysia, Morocco, Netherlands, New Zealand, Norway, Poland, South Korea, Singapore, South Africa, Spain and Sweden.
Product Description
Boston Scientific brand Zero Tip Nitinol Stone Retrieval Basket, 12 mm, 120 cm, 1.9 Fr., sterile, latex free; Catalog no. 390-105.
Manufacturer
Boston Scientific Corp

Device Recall ZeroP StarDrive Screwdriver Shaft

Model / Serial
Catalog # 03.617.902 - All lots
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Distributed Nationwide and Canada.
Product Description
Synthes Zero-P StarDrive Screwdriver Shaft, T8, self-retaining, quick coupling, for use in spinal fusion surgery. Catalog # 03.617.902 Technique Guide.
Manufacturer
Synthes Spine

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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