FDAFDA · Food and drugs·Recall number Z-2219-2014
VI DBL OFFST W/ LRG STPL, LT Nonsterile
Published August 20, 2014 · Recall initiated: July 23, 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
The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Zimmer, Inc.
- Distributor
- Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.
- Lot
- Item Number 82016757841 Lot Number 97009219, 97009254
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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