Reported Jun 15, 2022 · Completed
1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System
New Standard Device 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: New Standard Device Inc · 4848 Research Dr · San Antonio, TX · 78240-5005
Is this the product you have?
- 1.8mm Truss Wire
- REF900217, a Component of Metalogix Revolution External Plating System
- Lot codes and dates
- UDI854641008419
- LotsA29518X and A17219DA
- Amount recalled
- 426
Where it was sold
Why it was recalled
1.8mm truss wires are being removed to facilitate the introduction of 2.0mm truss wires. The increased wire diameter and new manufacturing process are meant to provide a stronger wire and reduced breakage.
This product could cause temporary or reversible health problems — stop using it.
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