FDAFDA · Food and drugs·Recall number Z-2247-2014
6.5 mm Cancellous Screw 16 mm Thread Length Sterile zimmer
Published August 27, 2014 · Recall initiated: July 22, 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
Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer, Inc.
- Distributor
- National Distribution: AK, AL, AZ, CA, CT, DC, FL, GA, US VIRGIN ISLANDS, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, VA, WA, WI, WV, WY Foreign Distribution: Canada, Mexico, ARGENTINA, AUSTRALIA, BELGIUM,BRAZIL, CHINA, EL SALVADOR, ENGLAND, GERMANY, INDIA, ITALY, JAPAN, JORDAN, KOREA, NEW ZEALAND, SAUDI ARABIA, SINGAPORE, SPAIN, SWITZERLAND, TAIWAN, UAE
- Lot
- Item Number 47-4865-030, 035, 040, 045, 050, 055, 060, 065, 070, 075, 080, 085, 090, 100-01
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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