Reported Dec 26, 2012 · Terminated
AutoTac Delivery Handle, REF 400-200, 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?
- AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.
- Lot codes and dates
- Lot Numbers
02070051040700300800152060700180801863080222508024690900838090175109021450902956100000310015041004620110130111018021103359110403211049761200616and 1202282
- Lot Numbers
- Amount recalled
- 174 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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