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Terminated

smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101

FDA Recall Z-0363-2022 · Posted None

Recalling FirmSmith & Nephew, Inc.
Recall StatusTerminated
Product CodeHRS
Date Initiated2021-11-01
Date Terminated2026-06-15
Product Quantity38 units

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.

Firm Action

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.

Root Cause

Under Investigation by firm

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K201918EVOS Large Fragment Plating SystemSmith & Nephew, Inc. · 2020-11-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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