Z-1236-2022Class II

1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System

Name: Z-1236-2022 1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System
Creator: New Standard Device Inc
Published: 2020-06-08
License: https://open.fda.gov/license/

Fusion Orthopedics USA, LLC / initiated 2020-06-08 / Completed / root cause: design

FDA source

New Standard Device Inc began a recall of 1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System on 2020-06-08. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as design.

Recall record

Recall number: Z-1236-2022
Classification: Class II
Status: Completed
Initiated: 2020-06-08
Posted: 2022-06-03
Recalling firm: Fusion Orthopedics USA, LLC
Product: 1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System
Product code: KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Reason for recall: 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 tag: design
FDA 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 in commerce: 426
Distribution: US Nationwide distribution in the states of AZ, VA, OH, CT, TX, NC, GA.
Product codes and lots: UDI: 854641008419, Lots: A29518X and A17219DA

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1236-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1236-2022	Class II	Completed	Voluntary: Firm initiated	2022-06-15	2022-06-03

Product code KTT

K181630Class IIRevolution External Plating SystemNew Standard Device Dba Metalogix / cleared 2019-05-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)