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Class 2 Device Recall Revolution External Fixation System |
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Date Initiated by Firm |
December 28, 2020 |
Create Date |
August 29, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1649-2022 |
Recall Event ID |
90670 |
510(K)Number |
K181630
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Product Classification |
Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
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Product |
Metalogix 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
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For Additional Information Contact |
Rachel Grimes 833-659-2019 Ext. 6
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Manufacturer Reason for Recall |
Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.
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FDA Determined Cause 2 |
Device Design |
Action |
On 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 Commerce |
410 total devices |
Distribution |
U.S.: AZ, GA, IL MT, NC, NJ, NV, OH, PA, TX, and VA
O.U.S.: None |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = KTT and Original Applicant = New Standard Device DBA Metalogix
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