FDA recall, , Moderate risk
Smith & Nephew EVOS Lateral Proximal Tibia Plate
A Partial Articular Lateral Proximal Tibia Plate implant was labeled and laser etched as a Lateral Proximal Tibia Plate.
Summary by Recall Canary from the FDA notice
What happened
Smith & Nephew, Inc., of Memphis, Tennessee, voluntarily recalled its EVOS 3.5MM Lateral Proximal Tibia Plate 6 Hole Left 91MM REF72463106 because the implant was incorrectly labeled and laser etched as a 3.5MM Partial Articular Lateral Proximal Tibia Plate 6 hole Left 91mm implant. The company began the recall on September 6, 2026, and it was added to the FDA's Enforcement Report on October 30, 2026.
The recalled product was distributed in Arizona, New Mexico, Nevada, New York, Texas, and Washington.
What to do
The FDA notice gives no instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
EVOS 3.5MM Lateral Proximal Tibia Plate 6 Hole Left 91MM REF72463106
- UDI-DI
- 00885556640401
- Lot code
- 25MM04429
Recall details
- Posted by FDA
- Recall began
- Status
- Open
- Weekly archive
- Listed the week of Oct 26, 2026
- Sold in
US Nationwide distribution in the states of Arizona, Nevada, Texas, New Mexico, Washington, New York.
- Recalled by
- Smith & Nephew, Inc.Memphis, Tennessee
- Hazard
- Labeling error
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- FDA event number
- 99904
- Recall number
- Z-0318-2027
- Quantity recalled
- 7 units
- Recall type
- Voluntary: Firm initiated
All recalls from Smith & Nephew, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
Smith & Nephew began the recall
FDA posted the recall to its Enforcement Report and rated it Class II (moderate risk)
Added to Recall Canary
