Reported Feb 26, 2014 · Terminated
External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx Only, BioHorizons(R), 2300 Riverchase…
BioHorizons Implant Systems Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: BioHorizons Implant Systems Inc · 2300 Riverchase Center · Birmingham, AL · 35244-2808
Is this the product you have?
- External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx Only, BioHorizons(R), 2300 Riverchase Center, Birmingham
- AL 35244 Usagedental
- Lot codes and dates
Lot Number 1302762Exp 31 MAY 2018
- Amount recalled
- 119 units
Where it was sold
Why it was recalled
The body length of the External Implant 40105D3 Lot 1302762 labeled as 10.5mm in length is in fact 12mm in length.
This product could cause temporary or reversible health problems — stop using it.
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