FDA-Device2014-05-21Class II
Cartilage Knee Brace***LATEX FREE" Product Usage: Used in the treatment and support of many types of knee injuries or following surgical and nonsurgical correction.
Zimmer, Inc.
Hazard
During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex.
Sold states
Worldwide Distribution - US Nationwide in the states of: AK, AZ, CA, FL, GA, IA, IL, IN, LA, MD, MI, MO NC, NE, NV, NY, OH, OK, OR, PA, RI, SD, TX, UT, VA, VT, WA, WI & WV and countries of: AUSTRALIA, CANADA, GERMANY, IRAQ, ITALY, SAUDI ARABIA, TUNISIA & UNITES ARAB EMIRATES.
Affected count
2,222 units
Manufactured in
1800 W Center St, Warsaw, IN, United States
Products
Cartilage Knee Brace***LATEX FREE" Product Usage: Used in the treatment and support of many types of knee injuries or following surgical and nonsurgical correction.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1604-2014Don't want to check this manually?
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