FDA Medical Device Recalls (openFDA)
New Standard Device Inc: Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A
- Recall number
- Z-1280-2022
- Recalling firm
- New Standard Device Inc
- Product
- Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A
- Status
- Open, Classified
- Initiated
- 2019-08-14
- Posted
- not on file
- Terminated
- not on file
- Reason
- Due to manufacturing processing error, wrench causing stripping when torqueing nuts.
- 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
- 14 devices
- Distribution
- U.S.: AZ. CT, GA, OH, and VA O.U.S.: N/A
- Lot, serial or model codes
- Catalog/Part Number: 900104 UDI-DI (GTIN): 854641008112 Lot Number: A29618A
- 510(k) numbers
- ["K181630"]
- PMA numbers
- not on file
- Product code
- HXC
- Firm FEI
- 3013365802
- Firm city
- San Antonio
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28