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U.S. Department of Health and Human Services

Class 2 Device Recall Revolution External Plating System

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  Class 2 Device Recall Revolution External Plating System see related information
Date Initiated by Firm July 23, 2019
Date Posted June 09, 2023
Recall Status1 Open3, Classified
Recall Number Z-1824-2023
Recall Event ID 92390
510(K)Number K181630  
Product Classification Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
Product 'n'-Hole Post which is a component of the Revolution External Fixation System

Catalog Numbers:
100801,
100802,
100803,
100804,
100805
Code Information Catalog Numbers / Lot Numbers: 100801 / A29318R 100802 / A29318S 100803 / A29318T 100804 / A29318U 100805 / A29318V UDI Codes: Not provided/None
Recalling Firm/
Manufacturer		 New Standard Device Inc
4848 Research Dr
San Antonio TX 78240-5005
For Additional Information Contact Rachel Grimes
833-659-2019 Ext. 6
Manufacturer Reason
for Recall		 The threads on posts stripping out when tensioned during application process.
FDA Determined
Cause 2		 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.life
Quantity in Commerce 222 units
Distribution U.S. Nationwide distribution in the states of AZ, CT, OH, TX, VA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KTT and Original Applicant = New Standard Device DBA Metalogix
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