Recall Z-1236-2022 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
New Standard Device Inc
1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System
| Date | Jun 8, 2020 |
| Status | Completed |
| Reason | 1.8mm truss wires are being removed to facilitate the introduction of 2.0mm truss wires. The increased wire diameter and new manufacturing process are meant to provide a stronger wire and reduced breakage. |
| Root cause | Device Design |
| Action | On 06/08/2020, Market Withdrawal notices were emailed to customers who were asked to remove affected truss wires from inventory and return to the recalling firm. Customers were informed to use alternate 1.8mm and 2.0mm unaffected smooth wires. Upon completion of verification testing, both 2.0mm truss and smooth wires will be released for use. Customers with additional questions are encouraged to call (833) 659-2019 Ext 6. |
| Quantity | 426 |
| Distribution | US Nationwide distribution in the states of AZ, VA, OH, CT, TX, NC, GA. |
| 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 |