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
    • 02070051
    • 04070030
    • 0800152
    • 06070018
    • 0801863
    • 0802225
    • 0802469
    • 0900838
    • 0901751
    • 0902145
    • 0902956
    • 1000003
    • 1001504
    • 1004620
    • 1101301
    • 1101802
    • 1103359
    • 1104032
    • 1104976
    • 1200616
    • and 1202282
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 24, 2013 · Data as of Sep 19, 5:35 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.