FDA Medical Device Recalls (openFDA)
New Standard Device Inc: 1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System
- Recall number
- Z-1236-2022
- Recalling firm
- New Standard Device Inc
- Product
- 1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System
- Status
- Completed
- Initiated
- 2020-06-08
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Device Design
- Action
- On 06/08/2020, Market Withdrawal notices were emailed to customers who were asked to remove affected truss wires from inventory and return to the recalling firm. Customers were informed to use alternate 1.8mm and 2.0mm unaffected smooth wires. Upon completion of verification testing, both 2.0mm truss and smooth wires will be released for use. Customers with additional questions are encouraged to call (833) 659-2019 Ext 6.
- Quantity
- 426
- Distribution
- US Nationwide distribution in the states of AZ, VA, OH, CT, TX, NC, GA.
- Lot, serial or model codes
- UDI: 854641008419, Lots: A29518X and A17219DA
- 510(k) numbers
- ["K181630"]
- PMA numbers
- not on file
- Product code
- KTT
- Firm FEI
- 3013365802
- Firm city
- San Antonio
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28