New Standard Device Inc 2022-06-15 Health serious FDA
Health · FDA · Recall #FDA-Z-1236-2022
1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System Recall
Issued June 15, 2022 · New Standard Device Inc
In June 2022, New Standard Device Inc recalled the 1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using 1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact New Standard Device Inc to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- New Standard Device Inc
- Category
- Health
- Recall date
- June 15, 2022
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the states of AZ, VA, OH, CT, TX, NC, GA.
- Recall number
- FDA-Z-1236-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- New Standard Device Inc has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.