'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805
This recall is currently active, issued June 9, 2023. It was issued by New Standard Device Inc.
- Company
- New Standard Device Inc
- Recall Initiated
- July 23, 2019
- Posted
- June 9, 2023
- Recall Number
- Z-1824-2023
- Quantity
- 222 units
- Firm Location
- San Antonio, TX
- Official Source
- View on FDA website ↗
Reason for Recall
The threads on posts stripping out when tensioned during application process.
Distribution
U.S. Nationwide distribution in the states of AZ, CT, OH, TX, VA.
Lot / Code Info
Catalog Numbers / Lot Numbers: 100801 / A29318R 100802 / A29318S 100803 / A29318T 100804 / A29318U 100805 / A29318V UDI Codes: Not provided/None
Root Cause
Under Investigation by firm
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