Data Foundry

Medical device recalls 2022

Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A — Class II medical device recall Z-1280-2022

Ongoing recall by New Standard Device Inc, reported 2022-06-29, distributed in AZ, CT, GA, OH, VA. Due to manufacturing processing error, wrench causing stripping when torqueing nuts.

Recall numberZ-1280-2022
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmNew Standard Device Inc, San Antonio, TX, United States
Recall initiated2019-08-14
Classified2022-06-21
Reported by FDA2022-06-29
DistributedAZ, CT, GA, OH, VA
Quantity14 devices
UPC / GTIN / UDI-DI00854641008112
Lot numbersA29618A
Model numbers900104

Product

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

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1280-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.