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U.S. Department of Health and Human Services

Class 2 Device Recall EVOS FLEX PLATE

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  Class 2 Device Recall EVOS FLEX PLATE see related information
Date Initiated by Firm November 29, 2017
Create Date January 24, 2018
Recall Status1 Terminated 3 on September 01, 2020
Recall Number Z-0408-2018
Recall Event ID 78672
510(K)Number K140814  
Product Classification Plate, fixation, bone - Product Code HRS
Product smith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate, REF CATALOG NUMBER 72442360N, NON-STERILE, Rx only, (01)00885556456446(10), (11)171116

Bone plates and bone screws from the EVOS Mini-Fragment Plating System are intended for use in internal fixation of small bones and small bone fragments and non-load bearing stabilization and reduction of bone fragments in long bones.
Code Information 17AM14602
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		 One lot of EVOS 2.4MM Flex Plate 6 Hole packaging contained templates.
FDA Determined
Cause 2		 Employee error
Action Smith & Nephew Inc. initiated its recall by email on November 29, 2017. The consignee was directed to return the recalled product. For further questions, please call (901) 396-2121.
Quantity in Commerce 12
Distribution US Distribution to the state of OR, and Internationally to Colombia.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HRS and Original Applicant = SMITH & NEPHEW, INC.
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