Z-1649-2022Class II

Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix...

Name: Z-1649-2022 Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix...
Creator: New Standard Device Inc
Published: 2020-12-28
License: https://open.fda.gov/license/

Fusion Orthopedics USA, LLC / initiated 2020-12-28 / Open, Classified / root cause: design

FDA source

New Standard Device Inc began a recall of Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030... on 2020-12-28. FDA classified it as Class II and gives the reason as "Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1649-2022
Classification: Class II
Status: Open, Classified
Initiated: 2020-12-28
Posted: 2022-08-29
Recalling firm: Fusion Orthopedics USA, LLC
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
Product code: KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Reason for recall: Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.
Root cause tag: design
FDA root cause: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1649-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1649-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-07	2022-08-29

Product code KTT

K181630Class IIRevolution External Plating SystemNew Standard Device Dba Metalogix / cleared 2019-05-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)