FDAFDA · Food and drugs·Recall number Z-0279-2018
Zimmer Dental GemLock RHD2.5 Hex Driver. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endosseous dental implants when tissue contact will last less than 1 hour.
Published December 27, 2017 · Recall initiated: October 11, 2017
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 device may contain a manufacturing condition affecting the geometry of the driver's hex feature which prevents it from properly engaging the fixture mount transfer and/or a dental implant.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer Dental Inc
- Distributor
- Worldwide Distribution: US (nationwide) and countries of: Canada, Australia, Belgium, Bulgaria, Chile, Costa Rica, Egypt, France, Georgia, Germany, Hong Kong, Hungary, Iran, Ireland, Israel, Italy, Japan, Lebanon, Lithuania, Netherlands, Nicaragua, Poland, Portugal, Romania, Serbia, Shanghai, Spain, Taiwan, Thailand, Tunisia, Turkey, UK, and United Arab Emirates.
- Lot
- Lot numbers 63563072, 63572755, 63583270, and 63755802
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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