Smith & Nephew EVOS tibia plate recalled for mislabeling
Smith & Nephew recalled seven units of the EVOS 3.5MM Lateral Proximal Tibia Plate, 6 Hole Left, 91MM. The implants were labeled and laser etched as a standard lateral tibia plate, but they are actually a partial articular version. No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All Smith & Nephew recalls
What to do
- Check inventory for lot 25MM04429 (UDI 00885556640401) and set any matching plates aside.
- Do not use affected plates until you have confirmed the correct product with the manufacturer or distributor.
- Contact Smith & Nephew or your distributor for return and replacement instructions.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- EVOS 3.5MM LATERAL PROXIMAL TIBIA PLATE 6 HOLE LEFT 91MM REF72463106
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
Details
- Units affected
- 7 units
- Illnesses reported
- None reported
- Manufactured in
- 1450 E Brooks Rd, Memphis, Tennessee, United States
- Classification
- Class II
- Recall number
- Z-0318-2027
In the FDA's words
- Description
- EVOS 3.5MM LATERAL PROXIMAL TIBIA PLATE 6 HOLE LEFT 91MM REF72463106 Incorrect labeling; 3.5MM Partial Articular Lateral Proximal Tibia Plate 6 hole Left 91MM implant labeled and lasered etched as as 3.5MM Lateral Proximal Tibia Plate 6 hole left 91mm implant Lot: 25MM04429/UDI: 00885556640401 Distribution: US Nationwide distribution in the states of AZ, NV, TX, NM, WA, NY. Affected quantity: 7 units
- Hazard
- Incorrect labeling; 3.5MM Partial Articular Lateral Proximal Tibia Plate 6 hole Left 91MM implant labeled and lasered etched as as 3.5MM Lateral Proximal Tibia Plate 6 hole left 91mm implant