smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202
Reported: December 22, 2021 Initiated: November 1, 2021 #Z-0366-2022
Product Description
smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202
Reason for Recall
Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System.
Details
- Recalling Firm
- Smith & Nephew, Inc.
- Units Affected
- 41 units
- Distribution
- US Nationwide distribution in the states of CO, FL, GA, MA, MN, MO, NC, NJ, NV, NY, OH, OK, PA, TN, TX, WA.
- Location
- Memphis, TN
Frequently Asked Questions
What product was recalled? ▼
smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202. Recalled by Smith & Nephew, Inc.. Units affected: 41 units.
Why was this product recalled? ▼
Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 22, 2021. Severity: Moderate. Recall number: Z-0366-2022.
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