Metalogix Self-Drill Half-Pin, a component of the… recallZ-1649-2022 · New Standard Device Inc · initiated Dec 28, 2020
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from New Standard Device Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.
FDA root cause category: Device Design
What the company is doing
On 12/28/2020, Metalogix send a "Field Notice: Self-Drill Half-Pin" via email. The Notice only informed customer that the Citieffe Half-Pins will temporarily be used to replace the current 5mm Self-Drill Half-Pins. A contact number for Mr. Elton Ely, QA Manager was provided in the notice 833-659-2019 ext. 6
Recall details
- Recall number
- Z-1649-2022
- Status
- Open, Classified
- Initiated by the company
- Dec 28, 2020
- Recalling firm
- New Standard Device Inc
- Quantity
- 410 total devices
- Product code
- KTT
- FDA submissions
- K181630
- Distribution
- U.S.: AZ, GA, IL MT, NC, NJ, NV, OH, PA, TX, and VA O.U.S.: None
Product description
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 Metalogix Self-Drill Half-Pin 5x60x215mm REF 620060 Metalogix Self-Drill Half-Pin 5x80x215mm REF 620080
Code information (models, lots, serial numbers)
Part Number / DESCRIPTION / UDI-DI Code / Lot Numbers: 620030 / Self-Drill Half-Pin 5x30x215mm / 854641008198 / A29418X, A17219CA 620040 / Self-Drill Half-Pin 5x40x215mm / 854641008204 / A29418Y, A17219CB 620060 / Self-Drill Half-Pin 5x60x215mm / 854641008211 / A29418Z, A17219CC 620080 / Self-Drill Half-Pin 5x80x215mm / 854641008228 / A29518A, A17219CD
Devices named in this recall
4 devices in the FDA device registry whose identifier appears in the recall's code information.
- Revolution External Plating System 620030Metalogix · Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component1 recall0 reports
- Revolution External Plating System 620040Metalogix · Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component1 recall0 reports
- Revolution External Plating System 620060Metalogix · Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component1 recall0 reports
- Revolution External Plating System 620080Metalogix · Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component1 recall0 reports
Other devices under the same FDA submission
2 devices cleared under K181630 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Revolution External Plating System 900104Metalogix · Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component1 recall0 reports
- Revolution External Plating System 900217Metalogix · Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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