Z-1280-2022Class II

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

Name: Z-1280-2022 Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A
Creator: New Standard Device Inc
Published: 2019-08-14
License: https://open.fda.gov/license/

Fusion Orthopedics USA, LLC / initiated 2019-08-14 / Open, Classified / root cause: manufacturing process

FDA source

New Standard Device Inc began a recall of Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A on 2019-08-14. FDA classified it as Class II and gives the reason as "Due to manufacturing processing error, wrench causing stripping when torqueing nuts". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1280-2022
Classification: Class II
Status: Open, Classified
Initiated: 2019-08-14
Posted: 2022-06-21
Recalling firm: Fusion Orthopedics USA, LLC
Product: Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A
Product code: HXC Wrench
Reason for recall: Due to manufacturing processing error, wrench causing stripping when torqueing nuts.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 08/19/2019, the firm sent via email an "FIELD SAFETY NOTICE" informing customers that the Slotted 90 degree Tubular Wrench was stripping when torqueing nuts in the application process. Customers were asked to: -remove the affected products from inventory and return to Metalogix Inc. at 4848 Research Drive, San Antonio, TX 78240 ATTENTION: QA Dept.
Quantity in commerce: 14 devices
Distribution: U.S.: AZ. CT, GA, OH, and VA O.U.S.: N/A
Product codes and lots: Catalog/Part Number: 900104 UDI-DI (GTIN): 854641008112 Lot Number: A29618A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1280-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1280-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-06-29	2022-06-21

Product code HXC

K181630Class IIRevolution External Plating SystemNew Standard Device Dba Metalogix / cleared 2019-05-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)