Use caution Medical device recall · FDA · Published May 27, 2021

Straumann SCS Screwdriver Recall: Incorrect Fit May Cause Injury

Straumann recalls dental screwdrivers with incorrect profile that may not fit screws, risking injury during dental procedures. Affected models include SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel (Article 046.4:01).

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

🇺🇸 FDA recall #Z-2198-2021Medical device Straumann ›

Use caution until it’s fixed

Tip of the screwdriver does not have the correct configuration / profile therefore the screwdriver does not properly fit the opposing screw head and cannot pick up the screws, may result in injury

Take action

Contact the company

Recalling firmStraumann USA LLC60 Minuteman Rd · Andover, MA 01810-1008

✎ GovInfoNow plain-language explainer

Straumann is recalling dental screwdrivers that may not fit screws properly, potentially causing injury. This affects specific models sold with a particular article number. The issue is due to an incorrect screwdriver profile that prevents secure screw engagement. Read more at govinfonow.com/recall/62470-straumann-scs-screwdriver-recall-incorrect-fit-may-cause-injury.

Source Summary by GovInfoNow · govinfonow.com/recall/62470-straumann-scs-screwdriver-recall-incorrect-fit-may-cause-injury · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2198-2021

Cite this page

“Straumann SCS Screwdriver Recall: Incorrect Fit May Cause Injury.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62470-straumann-scs-screwdriver-recall-incorrect-fit-may-cause-injury. Based on FDA recall #Z-2198-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2198-2021%22&limit=1).

Straumann USA LLC recalled the Straumann SCS Screwdriver due to a tip configuration that prevents proper screw pickup, which may result in injury, according to the FDA on May 27, 2021. The voluntary Class II recall involved 130 pieces distributed nationwide.

How to tell if you have it

Brand: Straumann
Product: Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel
Article Number: 046.401
Packaged lot number: EHG85
Lot Number engraved on part: CXV34

The hazard

The tip of the screwdriver does not have the correct configuration or profile, causing it to fail to properly fit the opposing screw head and pick up screws. This defect may result in injury.

Context

GovInfoNow's records show Straumann USA LLC has 13 other recalls on record since June 25, 2021. Recent brand recalls include a GM Helix Implant recall dated August 12, 2026, regarding packaging versus actual dimensions mismatch, and a Bone Level Tapered Implant recall from July 16, 2026, involving potential wrong length implants. Other recent recalls of similar products include the Tornier Perip Screw Recall (December 19, 2025), the Howmedica Osteonics MICS3 Angled Sagittal Saw Attachment Recall (February 2, 2026), and the Synthes 2.4V TAP CORTEX SCREW Recall (February 25, 2026).

How to tell if you have this one

Check for the model name 'SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel' and article number 046.401. The lot number on the package is EHG85 with part number CXV34.

Brand
Straumann
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the model name and article number on the product packaging.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 22 months after the firm started it.

May 27, 2021Firm started the recall
Aug 3, 2021FDA classified it Class II
Aug 11, 2021Published in FDA’s Enforcement Report
Mar 21, 2023FDA terminated the recall

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/62470-straumann-scs-screwdriver-recall-incorrect-fit-may-cause-injury">Straumann SCS Screwdriver Recall: Incorrect Fit May Cause Injury (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-2198-2021 (May 27, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2198-2021 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.