Smith & Nephew recalls Legion Hemi Step Tibial Wedge RK/HK implants due to incorrect screw packaging. This affects constrained knee surgery patients. Contact for replacement.
“Smith & Nephew Legion Hemi Step Tibial Wedge Recall: Incorrect Screw Component.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72134-smith-nephew-legion-hemi-step-tibial-wedge-recall-incorrect-screw. Based on FDA recall #Z-2538-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2538-2019%22&limit=1).
Smith & Nephew, Inc. recalled 12 units of LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK tibial wedge components on Jan. 15, 2018, because they were packaged with an incorrect screw component, the FDA said.
The affected products were inadvertently packaged with an incorrect screw component, according to the FDA.
Context
GovInfoNow's records show Smith & Nephew, Inc. has had 66 other recalls 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). Other recent recalls of similar products include U2 Total Knee System Femoral Offset Bushing Recall (March 19, 2026) and Straumann Dental Implant Abutments Recall (March 27, 2026).
How to tell if you have this one
Check for the product name 'LEGION HEMI STEP TIBIAL WEDGE RK/HK', size 3-4, and reference number 71423432. These implants are used in constrained knee surgeries.
Brand
Smith & Nephew
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Contact Manufacturer
Reach out to Smith & Nephew for guidance on the correct implant replacement.
How this recall unfolded
Recall timeline
FDA published this recall 20 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-2538-2019 (January 15, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2538-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 31, 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.