CLASS II ONGOING Device recall · Reported 29 Jun 2022 · FDA Enforcement Report

Metalogix Slotted 90 Tubular Wrench recalled by New Standard Device

New Standard Device is recalling Metalogix Slotted 90 Tubular Wrench, distributed in Arizona, Connecticut, Georgia, Ohio, Virginia. The recall was initiated on 14 Aug 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog/Part Number: 900104 UDI-DI (GTIN): 854641008112 Lot Number: A29618A

Quantity recalled14 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1280-2022
FDA event ID: 90159
Recalling firm: New Standard Device, San Antonio, TX
Classification: Class II
Status: Ongoing
Recall initiated: 14 Aug 2019
FDA classified: 21 Jun 2022
Reported: 29 Jun 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

14 Aug 2019	Recall initiated by company
21 Jun 2022	Classified by FDA	+1042 days
29 Jun 2022	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

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

Arizona Connecticut Georgia Ohio Virginia

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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