Recall Z-1236-2022— New Standard Device Inc
Class II · Completed
Class II FDA medical device recall by New Standard Device Inc, initiated 2020-06-08. It names one FDA 510(k) clearance: K181630. Product: 1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System. 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..
- Recalling firm
- New Standard Device Inc
- Classification
- Class II
- Status
- Completed
- Initiated
- 2020-06-08
- Firm location
- San Antonio, TX, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.