n'-Hole Post which is a component of the Revolution… recallZ-1824-2023 · New Standard Device Inc · initiated Jul 23, 2019
Class II Open, Classified All recalls posted in June 2023
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
The threads on posts stripping out when tensioned during application process.
FDA root cause category: Under Investigation by firm
What the company is doing
On 07/23/2019, the firm emailed a "FIELD SAFETY NOTICE" Letter to customers informing them that threads on posts were stripping out when tensioned during application process. Customers were instructed to: 1. Remove remaining POSTS from their inventory and return to Metalogix Inc. at 4848 Research Drive, San Antonio, TX 78240 Please label return package "ATTENTION: QA Dept" Metalogix Fed-Ex Account# 845 986 983 Metalogix will expedite new product back to customers For further information or questions, contact: Rachel Grimes, Quality Assurance Manager at 833-659-2019, EXT 6 [email protected]
Recall details
- Recall number
- Z-1824-2023
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Jul 23, 2019
- Posted by the FDA
- Jun 9, 2023
- Recalling firm
- New Standard Device Inc
- Quantity
- 222 units
- Product code
- KTT
- FDA submissions
- K181630
- Distribution
- U.S. Nationwide distribution in the states of AZ, CT, OH, TX, VA.
Product description
'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805
Code information (models, lots, serial numbers)
Catalog Numbers / Lot Numbers: 100801 / A29318R 100802 / A29318S 100803 / A29318T 100804 / A29318U 100805 / A29318V UDI Codes: Not provided/None
Other devices under the same FDA submission
6 devices cleared under K181630 — the recall does not name any of them by identifier. 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 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
- 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 18, 2026. Text above is shown as published by the FDA.
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