Reported Apr 29, 2015 · Terminated
Upper Right Telescope Unibodies (5/pk) and Upper Left Telescope Unibodies (54/pk) A Herbst Appliance is used to affect…
Specialty Appliance Works, 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: Specialty Appliance Works, Inc. · 4905 Hammond Industrial Dr · Cumming, GA · 30041-3914
Is this the product you have?
- Upper Right Telescope Unibodies (5/pk) and Upper Left Telescope Unibodies (54/pk) A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.
- Lot codes and dates
- Product No. 91695 and 91696
- Amount recalled
- 14,428 Universal Nuts
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.
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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