CLASS II ONGOING Device recall · Reported 7 Sep 2022 · FDA Enforcement Report

Metalogix Self-Drill Half-Pin recalled by New Standard Device

New Standard Device is recalling Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System, distributed in 11 states. The recall was initiated on 28 Dec 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart 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

Quantity recalled410 total devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1649-2022
FDA event ID: 90670
Recalling firm: New Standard Device, San Antonio, TX
Classification: Class II
Status: Ongoing
Recall initiated: 28 Dec 2020
FDA classified: 29 Aug 2022
Reported: 7 Sep 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Hip & Knee Implants

Timeline

28 Dec 2020	Recall initiated by company
29 Aug 2022	Classified by FDA	+609 days
7 Sep 2022	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

U.S.: AZ, GA, IL MT, NC, NJ, NV, OH, PA, TX, and VA O.U.S.: None

Arizona Georgia Illinois Montana North Carolina New Jersey Nevada Ohio Pennsylvania Texas Virginia

Questions about this recall

Is Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System recalled?

Yes. New Standard Device recalled Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System on 28 Dec 2020. The recall is Class II and its status is Ongoing. Recall number Z-1649-2022.

Why was it recalled?

Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.

Which lots are affected?

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

Where was it sold?

U.S.: AZ, GA, IL MT, NC, NJ, NV, OH, PA, TX, and VA O.U.S.: None

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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