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Lower risk Medical device recall · FDA · Published December 16, 2019

Smith & Nephew LEGION AP Cutting Blocks: Oversize Plunger Hole Hazard

Smith & Nephew recalls certain LEGION AP Cutting Blocks with oversize green plunger holes that may not meet design specs. Affected units include sizes 4, 6, 7, and 8 with specific lot numbers.

🇺🇸 FDA recall #Z-0878-2020Medical deviceSmith & Nephew ›
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Contact the company

Recalling firmSmith & Nephew, Inc.1450 E Brooks Rd · Memphis, TN 38116-1804
✎ GovInfoNow plain-language explainer

Smith & Nephew is recalling specific models of LEGION AP Cutting Blocks due to an oversize green plunger hole that could cause them to not meet design specifications. This issue may affect orthopedic surgical instruments used in procedures. Read more at govinfonow.com/recall/66315-smith-nephew-legion-ap-cutting-blocks-oversize-plunger-hole-hazard.

Source Summary by GovInfoNow · govinfonow.com/recall/66315-smith-nephew-legion-ap-cutting-blocks-oversize-plunger-hole-hazard · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0878-2020

Cite this page

“Smith & Nephew LEGION AP Cutting Blocks: Oversize Plunger Hole Hazard.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66315-smith-nephew-legion-ap-cutting-blocks-oversize-plunger-hole-hazard. Based on FDA recall #Z-0878-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0878-2020%22&limit=1).

Smith & Nephew, Inc. recalled LEGION AP Cutting Blocks due to manufacturing defects that do not meet design specifications, the FDA said on Dec. 16, 2019. The Food and Drug Administration announced the Class II recall of orthopaedic manual surgical instruments distributed in the U.S. and internationally.

How to tell if you have it

  • Brand: Smith & Nephew
  • Product: LEGION AP Cutting Block Size 4, REF 71434409
  • Product: LEGION AP Cutting Block Size 6, REF 71434411
  • Product: LEGION AP Cutting Block Size 7, REF 71434412
  • Product: LEGION AP Cutting Block Size 8, REF 71434413
  • Lot Numbers: 17LM05399, 17LM07852, 17LM07852A (Size 4)
  • Lot Numbers: 17LM05397, 17LM05398, 17LM07849 (Size 6)
  • Lot Numbers: 17LM01746, 17LM05390, 17LM05394, 17LM07851 (Size 7)
  • Lot Number: 17LM08442 (Size 8)
  • Units affected: 59

The hazard

Multiple lots of LEGION AP Femoral Cutting Blocks were manufactured with an oversize green plunger hole and therefore do not meet their design specifications.

Context

GovInfoNow's records show Smith & Nephew, Inc. has 66 other recalls on record since July 24, 2017. Other recent recalls of similar products include Smith & Nephew TRIGEN Humeral Nail Recall (March 16, 2026), Smith & Nephew BIOSURE HA Screw Recall (Nov. 24, 2025), and Smith & Nephew META-TAN Screw Kit Recall (March 18, 2025).

How to tell if you have this one

Check for the product name 'LEGION AP Cutting Block' with sizes 4, 6, 7, or 8. Look for specific lot numbers listed in the recall notice: 17LM05399, 17LM07852, 17LM07852A, 17LM05397, 17LM05398, 17LM07849, 17LM01746, 17LM05390, 17LM05394, 17LM07851, and 17LM08442.

  • Brand
    Smith & Nephew
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify the product size and lot number to confirm if it is affected by this recall.

Where it went and when

Where it was distributed

Distributed in 4 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: yesIAIndiana: not listedINOhio: not listedOHPennsylvania: yesPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “USA: IA, NC, PA, TN. Int'l: CH, BE, GB, AE, CN, DE, NL, BR, FR.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Iowa, North Carolina, Pennsylvania, Tennessee.

Recall timeline

FDA published this recall 51 days after the firm started it.

1. Firm started the recall: Dec 16, 201912. FDA classified it Class II: Jan 28, 202023. Published in FDA’s Enforcement Report: Feb 5, 2020320192020
  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.

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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-0878-2020 (December 16, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0878-2020 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