Recall Z-1280-2022 ยท HXC Wrench
New Standard Device Inc
Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A
| Date | Aug 14, 2019 |
| Status | Open, Classified |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181630 | Revolution External Plating System New Standard Device Dba Metalogix, May 29, 2019 |