—#190347

Product

smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102

FDA product code: HRS — Plate, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K201918
Affected lot / code info: Batch Number: 20HM10252, 20HM10253, 20HM10254, 20HM22785, UDI

Why it was 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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Smith & Nephew, Inc.
Address: 1450 E Brooks Rd, Memphis, Tennessee 38116-1804

Distribution

Distribution pattern: US Nationwide distribution in the states of CO, FL, GA, MA, MN, MO, NC, NJ, NV, NY, OH, OK, PA, TN, TX, WA.

Timeline

Recall initiated: 2021-11-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #190347. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.