FDA-Device2014-05-21Class II

Hinged Knee Support***LATEX FREE" Product Usage: Provide added lateral stability and allows the knee to tolerate more strenuous activity during recuperation.

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
546 units
Manufactured in
1800 W Center St, Warsaw, IN, United States
Products
Hinged Knee Support***LATEX FREE" Product Usage: Provide added lateral stability and allows the knee to tolerate more strenuous activity during recuperation.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1605-2014

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