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U.S. Department of Health and Human Services

Class 2 Device Recall EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE

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  Class 2 Device Recall EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE see related information
Date Initiated by Firm November 01, 2021
Create Date December 10, 2021
Recall Status1 Open3, Classified
Recall Number Z-0365-2022
Recall Event ID 89031
510(K)Number K201918  
Product Classification Plate, fixation, bone - Product Code HRS
Product smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102
Code Information Batch Number: 20HM10252, 20HM10253, 20HM10254, 20HM22785, UDI
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information Contact
901-396-2121
Manufacturer 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 2		 Under Investigation by 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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = HRS and Original Applicant = Smith & Nephew, Inc.
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