Reported Dec 26, 2012 · Terminated
Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.
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 Ctr · Birmingham, AL · 35244-2808
Is this the product you have?
- Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.
- Lot codes and dates
- Lot Numbers
61 of 61 codes
K0207015K0307007K0407011K0507007K0507008K0507010K0607003K0607008K0607009K0607017K0707010K0707014K0907001K0907009K0907011K1007006K1007007K1007008K1107009K1107010K1107012K1207002K0208005K0208005RK030800308001200800450080045108006740801215080125608017280801894080223208025280803139090002309008840901727090240209031450903480100005910014651002292100411810050551100381110080611010661101555110269911033901103811110407911047781105636120082912019781202444
- Lot Numbers
- Amount recalled
- 1246 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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