'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 1
FDA device recall Z-1824-2023 · posted 2023-06-09 · Open, Classified
Recall details
- Recalling firm
- New Standard Device Inc
- Reason for recall
- The threads on posts stripping out when tensioned during application process.
- Action taken
- 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.life
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- KTT
- Quantity affected
- 222 units
- Distribution
- U.S. Nationwide distribution in the states of AZ, CT, OH, TX, VA.
- Date initiated
- 2019-07-23
- Date posted
- 2023-06-09
- Location
- San Antonio, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Revolution External Plating System (K181630) | New Standard Device Dba Metalogix | 2019-05-29 |