Reported Sep 18, 2013 · Terminated
Brand Name: Vector TAS 8mm Screw. The Device Listing Number is E670535. Vector T AS 8mm Screw is intended to provide a…
Ormco/Sybronendo
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: Ormco/Sybronendo · 1332 S Lone Hill Ave · Glendora, CA · 91740-5339
Is this the product you have?
- Brand NameVector TAS 8mm Screw. The Device Listing Number is E670535. Vector T AS 8mm Screw is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and removed after orthodontic treatment has been completed. It is surgically placed in the bone of the upper or lower jaw arches to provide support for orthodontic devices
- Lot codes and dates
- Lot Number 1129118 MM Vector TAS Screw
- Part Number 601-0021 Lot Number 112911
Vector TAS Starter Kit (10 Patient)Part Number 601-0010
- Amount recalled
- 4,786
Where it was sold
- Nationwide
Why it was recalled
Ormco Corporation is voluntarily recalling one lot of 8 MM Vector TAS Screws because some screws of this lot were machined undersized at the top of the threads may potentially cause a weakening of the screw. Use of the undersized product may result in breakage of the screw during insertion or removal when torqued, possibly requiring surgical removal of any remaining pieces.
This product could cause temporary or reversible health problems — stop using it.
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