Recall Z-1824-2023 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
New Standard Device Inc
'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805
| Date | Jun 9, 2023 (initiated Jul 23, 2019) |
| Status | Open, Classified |
| Reason | The threads on posts stripping out when tensioned during application process. |
| Root cause | Under Investigation by firm |
| Action | On 07/23/2019, the firm emailed a "FIELD SAFETY NOTICE" Letter to customers informing them that threads on posts were stripping out when tensioned during application process. Customers were instructed to: 1. Remove remaining POSTS from their inventory and return to Metalogix Inc. at 4848 Research Drive, San Antonio, TX 78240 Please label return package "ATTENTION: QA Dept" Metalogix Fed-Ex Account# 845 986 983 Metalogix will expedite new product back to customers For further information or questions, contact: Rachel Grimes, Quality Assurance Manager at 833-659-2019, EXT 6 rachel@metalogix. |
| Quantity | 222 units |
| Distribution | U.S. Nationwide distribution in the states of AZ, CT, OH, TX, VA. |
| 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 |