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Ethicon Endo-Surgery Inc recalls PROXIMATE Skin Stapler. PROXIMATE RH Rotating-Head Skin Stapler (Model PRR35), PROXIMATE PX Fixed-Head Skin Stapler (
Recalled September 17, 2014 · FDA recall Z-2610-2014 · Ethicon Endo-Surgery
Hazard
The device may have a non-conforming component that may cause the device to fire an unformed staple. · FDA Class II
Units
42,798
Sold at
Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY; and countries of: Armenia, Belgium, Germany, Denmark, Finland, France, UK, Italy, Japan, South Korea, Netherlands, Norway, Russia, Sweden, Singapore, Taiwan, Tanzania, and South Africa.
Description
The device may have a non-conforming component that may cause the device to fire an unformed staple.
Product
PROXIMATE Skin Stapler. PROXIMATE RH Rotating-Head Skin Stapler (Model PRR35), PROXIMATE PX Fixed-Head Skin Stapler (Model PXR35), Bulk/Non-Sterile PROXIMATE RH Rotating-Head Skin Stapler (Model CK 117), and Bulk/Non-Sterile PROXIMATE PX Fixed-Head Skin Stapler (Model CK 158). Skin stapler for use in a single patient, which is designed to apply rectangular stainless steel staples for routine wound closure.
Manufacturer(s)
Ethicon Endo-Surgery Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →