Recall Z-0364-2022
Smith & Nephew, Inc. · initiated November 1, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
smith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201
Codes / lots: Batch Number: 20HM10255, 20HM10256, 20HM10257, UDI
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.
FDA-determined cause: Under Investigation by firm
Action taken
The firm initiated the correction by email and letter on 1 NOV 2021. The notice explained the problem and requested that the consignees check their inventory and complete the Inventory Correction Certificate form. Distributors were directed to notify their customers of the field action and ensure that these actions are carried out.
Details
- Recall number
- Z-0364-2022
- Initiated
- November 1, 2021
- Terminated
- June 15, 2026
- Product code
- HRS – Plate, Fixation, Bone
- Quantity
- 35 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.
- Recalling firm
- Smith & Nephew, Inc., Memphis, TN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0363-2022 Class II | smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports… | 11/01/2021Terminated |
| Z-0365-2022 Class II | smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports… | 11/01/2021Terminated |
| Z-0366-2022 Class II | smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports… | 11/01/2021Terminated |