New Standard Device Inc: Medical Device Recall in 2022 - (Recall #: Z-1280-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 14, 2019

Date Posted: June 29, 2022

Recall Number: Z-1280-2022

Event ID: 90159

Reason for Recall:

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

Status: Ongoing

Product Quantity: 14 devices

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

Voluntary or Mandated:

Voluntary: Firm initiated