FDAFDA · Food and drugs·Recall number Z-1058-2014
External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx Only, BioHorizons(R), 2300 Riverchase Center, Birmingham, AL 35244 Usage: dental
Published February 26, 2014 · Recall initiated: December 10, 2013
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 body length of the External Implant 40105D3 Lot 1302762 labeled as 10.5mm in length is in fact 12mm in length.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- BioHorizons Implant Systems Inc
- Distributor
- Worldwide distribution: US (nationwide) to states of: LA, CA, NC, IL, PA, and NY; and Internationally to: Seoul, Korea; New Delhi, India; Taipei City, Taiwan; and Madrid, Spain.
- Lot
- Lot Number 1302762, Exp 31 MAY 2018
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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