New Standard Device Inc recalls
Every recall we track for New Standard Device Inc — 4 in all, from 2019–2020 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
4 recalls since 2017.
All FDA recall records for New Standard Device Inc since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 2 | 0 | 2 |
| 2020 | 0 | 1 | 1 | 0 | 2 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled New Standard Device Inc product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All New Standard Device Inc recalls
4 shown- Use cautionMedical device
New Standard Device Inc recalls Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill
New Standard Device Inc recalls Metalogix Self-Drill Half-Pins due to reported tip breakages during surgery. Affected models include 5x30x215mm, 5x40x215mm, 5x60x215mm, and 5x80x215mm with specific lot numbers.
Metalogix Self-DrillDec 28, 2020 - Lower riskMedical device
New Standard Device Inc recalls 1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System
New Standard Device recalls 1.8mm truss wire (REF: 900217) used in Metalogix Revolution External Plating System. This component is being replaced with stronger 2.0mm wires to reduce breakage.
New Standard DeviceJun 8, 2020 - Lower riskMedical device
New Standard Device Inc recalls Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A
New Standard Device recalls 10mm slotted tubular wrenches with lot A29618A due to stripping nuts during use. Affected units may cause damage to fasteners.
New Standard DeviceAug 14, 2019 - Lower riskMedical device
New Standard Device Inc recalls 'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803,
New Standard Device recalls 'n'-Hole Post components (catalogs 100801-100805) due to thread stripping during application. Affected users should check their device model and contact for remedy.
New Standard DeviceJul 23, 2019
New Standard Device Inc recall questions
How many recalls has New Standard Device Inc had?
4 recalls from New Standard Device Inc are on record with U.S. safety agencies, from 2019–2020.
What is the most recent New Standard Device Inc recall?
New Standard Device Inc recalls Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill, dated Dec 28, 2020. Every New Standard Device Inc recall is listed on this page, newest first.
What should I do if I have a recalled New Standard Device Inc product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new New Standard Device Inc recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.