Reported May 20, 2015 · Terminated
Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in…
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 · Hoover, AL · 35244-2808
Is this the product you have?
- Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only
- Product Usage UsageSurgical instruments used in preparation for dental implant placement
- Lot codes and dates
- Lot Number 1501968
- Amount recalled
- 48 units
Where it was sold
Why it was recalled
BioHorizons Tapered HD Upgrade set was packaged with an incorrect drill component manufactured of stainless steel in place of the correct component manufactured from titanium.
This product could cause temporary or reversible health problems — stop using it.
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