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FDAFDA · Food and drugs·Recall number Z-1603-2014

DROP LOK" Knee Brace***LATEX FREE" Product Usage: Used in the treatment, support, and rehabilitation of many types of knee injuries or following surgical correction.

Published May 21, 2014 · Recall initiated: March 19, 2014

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Zimmer, Inc.
Distributor
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.
Lot
Model #: 00-1746-001-00 through 00-1746-006-00
Risk classification
Class II
Area (FDA)
device
Country
United States

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