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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 August 14, 2019
Create Date June 21, 2022
Recall Status1 Open3, Classified
Recall Number Z-1280-2022
Recall Event ID 90159
510(K)Number K181630  
Product Classification Wrench - Product Code HXC
Product Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A
Code Information Catalog/Part Number: 900104 UDI-DI (GTIN): 854641008112 Lot Number: A29618A
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		 Due to manufacturing processing error, wrench causing stripping when torqueing nuts.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On 08/19/2019, the firm sent via email an "FIELD SAFETY NOTICE" informing customers that the Slotted 90 degree Tubular Wrench was stripping when torqueing nuts in the application process. Customers were asked to: -remove the affected products from inventory and return to Metalogix Inc. at 4848 Research Drive, San Antonio, TX 78240 ATTENTION: QA Dept.
Quantity in Commerce 14 devices
Distribution U.S.: AZ. CT, GA, OH, and VA O.U.S.: N/A
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 = HXC and Original Applicant = New Standard Device DBA Metalogix
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