FDAFDA · Food and drugs·Recall number Z-1682-2016
VersaFx Femoral Fixation System Hex head compression screw 4.7 mm dia. 2 inch (51 mm) length 47116202400
Published May 25, 2016 · Recall initiated: May 4, 2016
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
A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer Manufacturing B.V.
- Distributor
- Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
- Lot
- LOT: 63290189
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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