Use caution Medical device recall · FDA · Published December 28, 2020

Metalogix Self-Drill Half-Pin Recall: Tip Breakage During Surgery

New Standard Device Inc recalls Metalogix Self-Drill Half-Pins due to reported tip breakages during surgery. Affected models include 5x30x215mm, 5x40x215mm, 5x60x215mm, and 5x80x215mm with specific lot numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1649-2022Medical device Metalogix Self-Drill ›

Use caution until it’s fixed

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

Take action

Contact the company

Recalling firmNew Standard Device Inc4848 Research Dr · San Antonio, TX 78240-5005

✎ GovInfoNow plain-language explainer

New Standard Device Inc is recalling Metalogix Self-Drill Half-Pins used in orthopedic surgery because they have broken during procedures. This could lead to complications if the pins fail while setting up a patient's external fixation system. Read more at govinfonow.com/recall/63593-metalogix-self-drill-half-pin-recall-tip-breakage-during-surgery.

Source Summary by GovInfoNow · govinfonow.com/recall/63593-metalogix-self-drill-half-pin-recall-tip-breakage-during-surgery · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1649-2022

Cite this page

“Metalogix Self-Drill Half-Pin Recall: Tip Breakage During Surgery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63593-metalogix-self-drill-half-pin-recall-tip-breakage-during-surgery. Based on FDA recall #Z-1649-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1649-2022%22&limit=1).

The FDA announced on 2020-12-28 that New Standard Device Inc is recalling Metalogix Self-Drill Half-Pins due to tip breakages during surgery. The recall affects 410 devices distributed in several U.S. states.

How to tell if you have it

Brand: Metalogix Self-Drill
Product: Metalogix Self-Drill Half-Pin (component of Revolution External Fixation System)
REF 620030 / Lot A29418X, A17219CA
REF 620040 / Lot A29418Y, A17219CB
REF 620060 / Lot A29418Z, A17219CC
REF 620080 / Lot A29518A, A17219CD

The hazard

According to the FDA, complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.

Context

GovInfoNow's records show New Standard Device Inc has issued three other recalls since 2019-07-23. Other recent recalls of similar products include Olympus PK Cutting Forceps Recall (2026-02-25), Intuitive Surgical da Vinci S/Si Mega Needle Driver Recall (2025-12-09), and Surgify Halo 5.4mm Drill Risk (2026-04-30).

How to tell if you have this one

Check for the model numbers: 5x30x215mm (REF 620030), 5x40x215mm (REF 620040), 5x60x215mm (REF 620060), or 5x80x215mm (REF 620080). Also look for lot numbers A29418X, A17219CA, A29418Y, A17219CB, A29418Z, A17219CC, A29518A, or A17219CD.

Brand
Metalogix Self-Drill
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the model number and lot numbers listed in the recall notice to confirm if your item is affected.
Contact Manufacturer
Reach out to New Standard Device Inc for guidance on next steps if your item is recalled.

Where it went and when

Where it was distributed

Distributed in 11 states.

FDA distribution: “U.S.: AZ, GA, IL MT, NC, NJ, NV, OH, PA, TX, and VA O.U.S.: None” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, Georgia, Illinois, Montana, Nevada, New Jersey, North Carolina, Ohio, Pennsylvania, Texas, Virginia.

Recall timeline

FDA published this recall 20 months after the firm started it.

Dec 28, 2020Firm started the recall
Aug 29, 2022FDA classified it Class II
Sep 7, 2022Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/63593-metalogix-self-drill-half-pin-recall-tip-breakage-during-surgery">Metalogix Self-Drill Half-Pin Recall: Tip Breakage During Surgery (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1649-2022 (December 28, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1649-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.