'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805
- 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
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