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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 Systemsee related information
Date Initiated by FirmAugust 14, 2019
Create DateJune 21, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1280-2022
Recall Event ID 90159
510(K)NumberK181630 
Product Classification Wrench - Product Code HXC
ProductMetalogix 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 ContactRachel 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
ActionOn 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 Commerce14 devices
DistributionU.S.: AZ. CT, GA, OH, and VA O.U.S.: N/A
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = HXC
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