Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT… recallZ-1280-2022 · New Standard Device Inc · initiated Aug 14, 2019
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
Due to manufacturing processing error, wrench causing stripping when torqueing nuts.
FDA root cause category: Nonconforming Material/Component
What the company is doing
On 08/19/2019, the firm sent via email an "FIELD SAFETY NOTICE" informing customers that the Slotted 90 degree Tubular Wrench was stripping when torqueing nuts in the application process. Customers were asked to: -remove the affected products from inventory and return to Metalogix Inc. at 4848 Research Drive, San Antonio, TX 78240 ATTENTION: QA Dept.
Recall details
- Recall number
- Z-1280-2022
- Status
- Open, Classified
- Initiated by the company
- Aug 14, 2019
- Recalling firm
- New Standard Device Inc
- Quantity
- 14 devices
- Product code
- HXC
- FDA submissions
- K181630
- Distribution
- U.S.: AZ. CT, GA, OH, and VA O.U.S.: N/A
Product description
Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A
Code information (models, lots, serial numbers)
Catalog/Part Number: 900104 UDI-DI (GTIN): 854641008112 Lot Number: A29618A
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Revolution External Plating System 900104Metalogix · Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component1 recall0 reports
Other devices under the same FDA submission
5 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 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 16, 2026. Text above is shown as published by the FDA.
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