Lower risk Medical device recall · FDA · Published October 25, 2021

Smith & Nephew EVOS Screws: Switched Labels May Cause Confusion

Smith & Nephew recalls two sterile screw models due to switched labels on packages. This could lead to using the wrong screw size in medical procedures. Affected units have specific batch numbers.

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

🇺🇸 FDA recall #Z-0265-2022Medical device Smith & Nephew ›

Lower-risk recall

The labels on the packages of screws were switched.

Take action

Contact the company

Recalling firmSmith & Nephew, Inc.1450 E Brooks Rd · Memphis, TN 38116-1804

✎ GovInfoNow plain-language explainer

Smith & Nephew is recalling two sterile self-tapping locking screws because the labels on their packaging were switched. This could cause confusion about which screw size is being used, potentially leading to incorrect medical procedures. Read more at govinfonow.com/recall/61631-smith-nephew-evos-screws-switched-labels-may-cause-confusion.

Source Summary by GovInfoNow · govinfonow.com/recall/61631-smith-nephew-evos-screws-switched-labels-may-cause-confusion · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0265-2022

Cite this page

“Smith & Nephew EVOS Screws: Switched Labels May Cause Confusion.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61631-smith-nephew-evos-screws-switched-labels-may-cause-confusion. Based on FDA recall #Z-0265-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0265-2022%22&limit=1).

Smith & Nephew, Inc. recalled Smith and Nephew EVOS Self-Tapping Locking Screw SST units due to switched package labels, the FDA said on Oct. 25, 2021.

How to tell if you have it

Brand: Smith & Nephew
Product: Smith and Nephew EVOS Self-Tapping Locking Screw SST
REF 72413575, 3.5MM x 75MM, batch #21FM24289
REF 72413570, 3.5MM X 70MM, batch #21GM04743
Quantity: 224 units

The hazard

The labels on the packages of screws were switched, according to the FDA.

Context

GovInfoNow's records show Smith & Nephew, Inc. has had 66 other recalls since July 24, 2017. Recent Smith & Nephew recalls include the March 16, 2026 TRIGEN Humeral Nail Recall and the Nov. 24, 2025 BIOSURE HA Screw Recall. Other recent recalls of similar products include the Dec. 19, 2025 Tornier Perip Screw Recall, the Feb. 18, 2026 XTANT Medical Xpress Pedicle Screw System recall, and the Jan. 9, 2026 APTUS 2.8 TriLock Screw Recall.

How to tell if you have this one

Check the package for batch numbers: REF 72413575 (batch #21FM24289) or REF 72413570 (batch #21GM04743). The screws are sterile and come in 3.5mm x 75mm or 3.5mm x 70mm sizes.

Brand
Smith & Nephew
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Package Labels
Look for the batch numbers: REF 72413575 (batch #21FM24289) or REF 72413570 (batch #21GM04743).

Where it went and when

Where it was distributed

Distributed in 25 states, and outside the U.S.

FDA distribution: “Distribution was made to AL, AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, ME, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TN, TX, and WA. There was no direct government distribution. There was no military distribution. Foreign distribution was made…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Minnesota, Missouri, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Washington.

Recall timeline

FDA published this recall 30 days after the firm started it.

Oct 25, 2021Firm started the recall
Nov 18, 2021FDA classified it Class II
Nov 24, 2021Published 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/61631-smith-nephew-evos-screws-switched-labels-may-cause-confusion">Smith &amp; Nephew EVOS Screws: Switched Labels May Cause Confusion (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-0265-2022 (October 25, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0265-2022 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.