FDAFDA · Food and drugs·Recall number Z-1606-2014
Tennis Elbow Support, Neoprene***LATEX FREE" Product Usage: Provides compression and warmth for mild to moderate elbow strains and sprains.
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 #: 00-3448-003-00 through 00-3448-006-00
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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