FDAFDA · Food and drugs·Recall number Z-1842-2014
VerSys¿ Hip System, Beaded Fullcoat Stems, Zimmer, Inc., Warsaw, IN 46581
Published July 2, 2014 · Recall initiated: May 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 routine inspection, beaded hip stem forgings received from supplier failed to meet ZES 2A-102. Processing of Beaded CoCrMo Alloy Hip Stem, material requirements per ATS #14-04818 and ATS #14-05549, respectively.
What to do
Voluntary: Firm initiated · Other
Recall details
- Manufacturer
- Zimmer, Inc.
- Distributor
- Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, CO, CT, FL, GA, IL, IN, MA, MI, MN, NC, ND, NJ, NY, OH, OK, PA, TN, TX, VA & WI, and the countries of Canada, Colombia, Dominican Republic, Japan, Korea (S. Korea), Peru, Taiwan & Thailand.
- Lot
- Item # 784301108, Lot #'s: 62478967, 62479742, 62503408, 62528282, 62530786, 62544915, 62554360; Item # 784301126, Lot #: 62544885, 62547211, Item # 784301156, Lot #, 62587079; Item # 784301208, Lot #'s: 62503411, 62509385, 62530790, 62547217, 62554362; Item # 784301226, Lot #'s: 62515502, 62547216; Item # 784301256, Lot #'s: 62489572, 62522386; Item # 784301326, Lot #, 62496464, 62594428, 62622893; Item # 784301356, Lot #: 62622894; Item # 784301382, Lot #: 62544907; Item # 784301511, Lot #: 62472423 & Item # 784301581, Lot #: 62496469.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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