San Antonio, TX, United States
New Standard Device Inc recalls
4 recalls recorded since 2018, most recently on 28 December 2020. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)3
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 28 December 2020
- Reason
- Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.
- Distribution
- U.S.: AZ, GA, IL MT, NC, NJ, NV, OH, PA, TX, and VA O.U.S.: None
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1649-2022
- Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030 Metalogix Self-Drill Half-Pin 5x40x215mm REF 620040 Me
Completed Class II Medical devices
- Recall started
- 8 June 2020
- 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.
- Distribution
- US Nationwide distribution in the states of AZ, VA, OH, CT, TX, NC, GA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1236-2022
- 1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System
Ongoing Class II Medical devices
- Recall started
- 14 August 2019
- Reason
- Due to manufacturing processing error, wrench causing stripping when torqueing nuts.
- Distribution
- U.S.: AZ. CT, GA, OH, and VA O.U.S.: N/A
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1280-2022
- Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A
Ongoing Class II Medical devices
- Recall started
- 23 July 2019
- Reason
- The threads on posts stripping out when tensioned during application process.
- Distribution
- U.S. Nationwide distribution in the states of AZ, CT, OH, TX, VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1824-2023
- 'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.