FDA Recalls Metalogix Slotted 90 Tubular Wrench Due to Manufacturing Error
New Standard Device Inc is recalling 14 Metalogix Slotted 90 Tubular Wrenches (Lot A29618A) due to a manufacturing error that causes the wrench to strip nuts when torqueing. No injuries have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm medical device with a functional defect that could compromise proper assembly. No injuries, illnesses, or hospitalizations have been reported in the source, so the score is 3 (High) per the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
New Standard Device Inc is recalling 14 Metalogix Slotted 90 Tubular Wrenches (Model 900104, Lot A29618A) distributed in the United States. The wrenches are subject to a manufacturing processing error that causes the wrench to strip nuts when torqueing.
The manufacturing defect results in improper wrench function, which may cause fastener stripping during use. Depending on the application, this could lead to loose or improperly secured connections.
The affected devices were distributed to users in Arizona, Connecticut, Georgia, Ohio, and Virginia. Fourteen devices have been identified in this recall lot.
Users and consumers who have this wrench should immediately discontinue use and contact New Standard Device Inc for replacement or return instructions. No injuries or illnesses have been reported to date.
The recalled product
- Product
- Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A
- Manufacturer
- New Standard Device Inc
- Category
- Medical Device
- Hazard
- tool-defect
- fastener-stripping
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog/Part Number: 900104 UDI-DI (GTIN): 854641008112 Lot Number: A29618A
Distribution
Distributed in 5 states:
- AZ
- CT
- GA
- OH
- VA
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