1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System
Reported: June 15, 2022 Initiated: June 8, 2020 #Z-1236-2022
Product Description
1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System
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.
Details
- Recalling Firm
- New Standard Device Inc
- Units Affected
- 426
- Distribution
- US Nationwide distribution in the states of AZ, VA, OH, CT, TX, NC, GA.
- Location
- San Antonio, TX
Frequently Asked Questions
What product was recalled? ▼
1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System. Recalled by New Standard Device Inc. Units affected: 426.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 15, 2022. Severity: Moderate. Recall number: Z-1236-2022.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11