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Lower risk Medical device recall · FDA · Published January 4, 2022

Smith & Nephew INTEGRA SURFIX ALPHA Screwdriver Torx 10 Recall: May Not Mate With Lock

Smith & Nephew recalls INTEGRA SURFIX ALPHA Torx 10 screwdrivers that may not properly engage with Surfix Alpha Lock screws, causing potential assembly issues.

🇺🇸 FDA recall #Z-0548-2022Medical deviceSmith & Nephew ›
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Recalling firmSmith & Nephew, Inc.1450 E Brooks Rd · Memphis, TN 38116-1804
✎ GovInfoNow plain-language explainer

Smith & Nephew is recalling INTEGRA SURFIX ALPHA Torx 10 screwdrivers that may not fit correctly with Surfix Alpha Lock screws. This could lead to improper assembly or damage during use. Read more at govinfonow.com/recall/61320-smith-nephew-integra-surfix-alpha-screwdriver-torx-10-recall-may.

Source Summary by GovInfoNow · govinfonow.com/recall/61320-smith-nephew-integra-surfix-alpha-screwdriver-torx-10-recall-may · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0548-2022

Cite this page

“Smith & Nephew INTEGRA SURFIX ALPHA Screwdriver Torx 10 Recall: May Not Mate With Lock.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61320-smith-nephew-integra-surfix-alpha-screwdriver-torx-10-recall-may. Based on FDA recall #Z-0548-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0548-2022%22&limit=1).

Smith & Nephew, Inc. voluntarily recalled INTEGRA SURFIX ALPHA Screwdriver Torx 10 units nationwide on Jan. 4, 2022, according to the FDA. The devices are out of specification and may not mate with the Surfix Alpha Lock screw.

How to tell if you have it

  • INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND
  • UPC 10381780052234
  • Batch Numbers: FTL9, FTLA, and FVRG

The hazard

The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw.

Context

GovInfoNow's records show Smith & Nephew, Inc. has had 66 other recalls on record since July 24, 2017. Other recent recalls of similar products include Synthes 2.4V Tap Locking Screw Tap Recall (Feb. 25, 2026), Smith & Nephew BIOSURE HA Screw Recall (Nov. 24, 2025), and Genesis Screw-In Anchor Recall (Dec. 17, 2025).

How to tell if you have this one

Check for the model name 'INTEGRA SURFIX ALPHA Screwdriver Torx 10' and batch numbers FTL9, FTLA, or FVRG. The unique device identifier (UDI) starts with (01)10381780052234 or (11)21101.

  • Brand
    Smith & Nephew
  • Product
    INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify the batch numbers (FTL9, FTLA, FVRG) and unique device identifier (UDI) on the screwdriver.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 2 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: nationwideFL

FDA distribution: “US Nationwide distribution in the states of CA and OH.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Ohio.

Recall timeline

FDA published this recall 36 days after the firm started it.

1. Firm started the recall: Jan 4, 202212. FDA classified it Class II: Feb 1, 202223. Published in FDA’s Enforcement Report: Feb 9, 202232022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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

✎ GovInfoNow

Questions people ask

What should I do if I have this screwdriver?

Check the batch numbers and UDI to confirm if it's affected; no specific action is required beyond verification.

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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-0548-2022 (January 4, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0548-2022 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA