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U.S. Department of Health and Human Services

Class 2 Device Recall Revolution External Fixation System

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 Class 2 Device Recall Revolution External Fixation Systemsee related information
Date Initiated by FirmDecember 28, 2020
Create DateAugust 29, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1649-2022
Recall Event ID 90670
510(K)NumberK181630 
Product Classification Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
ProductMetalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030 Metalogix Self-Drill Half-Pin 5x40x215mm REF 620040 Metalogix Self-Drill Half-Pin 5x60x215mm REF 620060 Metalogix Self-Drill Half-Pin 5x80x215mm REF 620080
Code Information Part Number / DESCRIPTION / UDI-DI Code / Lot Numbers: 620030 / Self-Drill Half-Pin 5x30x215mm / 854641008198 / A29418X, A17219CA 620040 / Self-Drill Half-Pin 5x40x215mm / 854641008204 / A29418Y, A17219CB 620060 / Self-Drill Half-Pin 5x60x215mm / 854641008211 / A29418Z, A17219CC 620080 / Self-Drill Half-Pin 5x80x215mm / 854641008228 / A29518A, A17219CD
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		Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.
FDA Determined
Cause 2		Device Design
ActionOn 12/28/2020, Metalogix send a "Field Notice: Self-Drill Half-Pin" via email. The Notice only informed customer that the Citieffe Half-Pins will temporarily be used to replace the current 5mm Self-Drill Half-Pins. A contact number for Mr. Elton Ely, QA Manager was provided in the notice 833-659-2019 ext. 6
Quantity in Commerce410 total devices
DistributionU.S.: AZ, GA, IL MT, NC, NJ, NV, OH, PA, TX, and VA O.U.S.: None
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 = KTT
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