Recall Z-1280-2022— New Standard Device Inc

Name: FDA recall Z-1280-2022
Creator: U.S. Food and Drug Administration
Published: 2019-08-14

Class II · Ongoing

Class II FDA medical device recall by New Standard Device Inc, initiated 2019-08-14. It names one FDA 510(k) clearance: K181630. Product: Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A. Reason: Due to manufacturing processing error, wrench causing stripping when torqueing nuts..

Recalling firm: New Standard Device Inc
Classification: Class II
Status: Ongoing
Initiated: 2019-08-14
Firm location: San Antonio, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K181630 — Revolution External Plating SystemNew Standard Device Dba Metalogix·cleared 2019-05-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.