| Class 2 Device Recall EVOS FLEX PLATE | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = HRS
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