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Recall Observatory FDA recall evidence

Device product

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

Z-1280-2022

August 14, 2019

Class II

Product summary

Firm
New Standard Device Inc
Event
Event 90159
Status
Ongoing
Classification
Class II
Quantity
14 devices
Official record key
device-enforcement:Z-1280-2022

Official wording

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

Code information: Catalog/Part Number: 900104 UDI-DI (GTIN): 854641008112 Lot Number: A29618A

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

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    manufacturing processing error