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ArthroCare Corporation recalls Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971
Recalled September 30, 2020 · FDA recall Z-3000-2020 · ArthroCare
Hazard
The voluntary recall is being initiated due to a manufacturing error resulting in incorrect upper jaw dimensions, and the upper jaw could potentially disengage or detach during use. · FDA Class II
Units
15,559 units
Sold at
US: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, ON, OR, PA, SC, SG, TN, TX, UT, VA, WA, WI, WV OUS: Austria, Belgium, Canada, Switzerland, Germany, Denmark, France, England, Ireland, India, Netherlands, Norway, Poland, Puerto Rico, Russia, Singapore, Turkey, United Arab Emirates, South Africa)
Description
The voluntary recall is being initiated due to a manufacturing error resulting in incorrect upper jaw dimensions, and the upper jaw could potentially disengage or detach during use.
Product
Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971
Manufacturer(s)
ArthroCare Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →