Lower riskMedical device recall · FDA · Published April 9, 2018
Smith & Nephew Genesis II Knee Bushing Recall: Laser Marking Error
Smith & Nephew recalls Genesis II knee bushings with a laser marking error that could cause incorrect implant placement. Affected units have a specific lot number and require verification.
A single lot of GENESIS II FEMORAL FIVE DEGREE VALGUS BUSHING due to a laser mark labeling error. The left valgus bushing was incorrectly laser marked as right and vice versa.
“Smith & Nephew Genesis II Knee Bushing Recall: Laser Marking Error.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71493-smith-nephew-genesis-ii-knee-bushing-recall-laser-marking-error. Based on FDA recall #Z-1902-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1902-2018%22&limit=1).
The FDA announced on April 9, 2018, that Smith & Nephew, Inc. recalled the smith&nephew 5o GENESIS II VALGUS BUSHING due to a laser mark labeling error. The agency classified the recall as Class II.
How to tell if you have it
Brand: Smith & Nephew
Product: smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 71440014
Lot number: 16MM00441
The hazard
A single lot of the GENESIS II FEMORAL FIVE DEGREE VALGUS BUSHING was affected by a laser mark labeling error. The left valgus bushing was incorrectly laser marked as right and vice versa.
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 the Smith & Nephew TRIGEN Humeral Nail Recall (March 16, 2026), the Smith & Nephew BIOSURE HA Screw Recall (November 24, 2025), and the Smith & Nephew META-TAN Screw Kit Recall (March 18, 2025). Other recent recalls of similar products include the U2 Total Knee System Femoral Offset Bushing Recall (March 19, 2026) and the EMPOWR 3D KNEE Implants Have Incorrect Labeling - Recall Notice (January 15, 2026).
How to tell if you have this one
Check for the lot number 16MM00441 on the Genesis II knee bushing. The product is part of the Smith & Nephew Genesis II Knee System with catalog number 71440014.
Brand
Smith & Nephew
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Verify Lot Number
Check the lot number on the bushing; affected units have lot number 16MM00441.
Where it went and when
Where it was distributed
Distributed in 9 states.
Listed by the agency
Not listed
FDA distribution: “US Distribution to the states of : NC, IN, CO MI, PA, NY, MA, CA, GA” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Colorado, Georgia, Indiana, Massachusetts, Michigan, New York, North Carolina, Pennsylvania.
Recall timeline
FDA terminated this recall 10 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-1902-2018 (April 9, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1902-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 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.