Recall Z-1649-2022 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
New Standard Device Inc
Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030 Metalogix Self-Drill Half-Pin 5x40x215mm REF 620040 Metalogix Self-Drill Half-Pin 5x60x215mm REF 620060 Metalogix Self-Drill Half-Pin 5x80x215mm REF 620080
| Date | Dec 28, 2020 |
| Status | Open, Classified |
| Reason | Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery. |
| Root cause | Device Design |
| Action | On 12/28/2020, Metalogix send a "Field Notice: Self-Drill Half-Pin" via email. The Notice only informed customer that the Citieffe Half-Pins will temporarily be used to replace the current 5mm Self-Drill Half-Pins. A contact number for Mr. Elton Ely, QA Manager was provided in the notice 833-659-2019 ext. 6 |
| Quantity | 410 total devices |
| Distribution | U.S.: AZ, GA, IL MT, NC, NJ, NV, OH, PA, TX, and VA O.U.S.: None |
| 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 |