Lower riskMedical device recall · FDA · Published February 1, 2018
Smith & Nephew Legion HK Femoral Wedge (Wedge and Screw) Recall: 5mm screws too short
Smith & Nephew recalls Legion HK Femoral Wedge (Wedge and Screw) 5mm size due to screws being 5mm instead of 10mm, which can't be used with the device. Affected items have batch number 14AAP6352A.
“Smith & Nephew Legion HK Femoral Wedge (Wedge and Screw) Recall: 5mm screws too short.” GovInfoNow, updated August 28, 2026. https://govinfonow.com/recall/72066-smith-nephew-legion-hk-femoral-wedge-wedge-and-screw-recall. Based on FDA recall #Z-1105-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1105-2018%22&limit=1).
The FDA announced on Feb. 1, 2018, that Smith & Nephew, Inc. recalled smith&nephew, LEGION HK FEMORAL WEDGE (WEDGE AND SCREW), 5 MM, SIZE 5 units because the screws were too short for use with the Legion HK Distal Wedge Size 5.
How to tell if you have it
Brand: Smith & Nephew
Product: smith&nephew, LEGION HK FEMORAL WEDGE (WEDGE AND SCREW), 5 MM, SIZE 5
REF: 71422159
Lot code: 14AAP6352A
Quantity: 28 units
The hazard
The screws packaged with devices within lot 14AAP6352A were 5 MM instead of the required 10 MM, making them too short to be used with the Legion HK Distal Wedge Size 5.
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 the Smith & Nephew TRIGEN Humeral Nail Recall (March 16, 2026), the Smith & Nephew BIOSURE HA Screw Recall (Nov. 24, 2025), and the Smith & Nephew META-TAN Screw Kit Recall (March 18, 2025). Other recent recalls of similar products include the Tornier Perip Screw Recall (Dec. 19, 2025), the Straumann Bone Level Tapered Implant May Be Wrong Length - Recall (July 16, 2026), and the Charlotte Claw Screw Recall (Aug. 18, 2026).
How to tell if you have this one
Check for the batch number 14AAP6352A on the packaging of the Legion HK Femoral Wedge (Wedge and Screw) 5mm, Size 5, REF 71422159. This product is used in revision knee surgery for specific patient conditions.
Brand
Smith & Nephew
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Batch
Look for the batch number 14AAP6352A on the packaging of the Legion HK Femoral Wedge (Wedge and Screw) 5mm, Size 5, REF 71422159.
Where it went and when
Where it was distributed
Distributed in 5 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “Worldwide Distribution - US Distribution to the states of: NY, IL, NJ, TX, CO, and to the countries of : Belgium, Great Britain, Australia, Germany, Netherlands, Norway.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Colorado, Illinois, New Jersey, New York, Texas.
Recall timeline
FDA terminated this recall 9 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-1105-2018 (February 1, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1105-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 28, 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.