FDA-Device2014-08-27Class II
6.5 mm Cancellous Screw Fully Threaded Sterile zimmer
Zimmer, Inc.
Hazard
Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.
Sold states
National Distribution: AK, AL, AZ, CA, CT, DC, FL, GA, US VIRGIN ISLANDS, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, VA, WA, WI, WV, WY Foreign Distribution: Canada, Mexico, ARGENTINA, AUSTRALIA, BELGIUM,BRAZIL, CHINA, EL SALVADOR, ENGLAND, GERMANY, INDIA, ITALY, JAPAN, JORDAN, KOREA, NEW ZEALAND, SAUDI ARABIA, SINGAPORE, SPAIN, SWITZERLAND, TAIWAN, UAE
Affected count
47,682 units total
Manufactured in
1800 W Center St, Warsaw, IN, United States
Products
6.5 mm Cancellous Screw Fully Threaded Sterile zimmer
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2249-2014Don't want to check this manually?
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