Z-1280-2022 Class II Ongoing
FDA device recall Z-1280-2022 was initiated by New Standard Device Inc on August 14, 2019 and is designated Class II. Reason for recall: Due to manufacturing processing error, wrench causing stripping when torqueing nuts. The recall status is ongoing. Affected quantity: 14 devices.
Recall Details
- Product Type
- Devices
- Report Date
- June 29, 2022
- Initiation Date
- August 14, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14 devices
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.
Distribution Pattern
U.S.: AZ. CT, GA, OH, and VA O.U.S.: N/A
Code Information
Catalog/Part Number: 900104 UDI-DI (GTIN): 854641008112 Lot Number: A29618A