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Open, Classified

Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A

FDA Recall Z-1280-2022 · Posted None

Recalling FirmNew Standard Device Inc
Recall StatusOpen, Classified
Product CodeHXC
Date Initiated2019-08-14
Product Quantity14 devices

Reason for Recall

Due to manufacturing processing error, wrench causing stripping when torqueing nuts.

Firm Action

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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

U.S.: AZ. CT, GA, OH, and VA O.U.S.: N/A

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K181630Revolution External Plating SystemNew Standard Device Dba Metalogix · 2019-05-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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