| Class 2 Device Recall Bone screws | |
Date Initiated by Firm | August 24, 2020 |
Create Date | September 09, 2020 |
Recall Status1 |
Terminated 3 on July 11, 2022 |
Recall Number | Z-2945-2020 |
Recall Event ID |
86342 |
510(K)Number | K140814 |
Product Classification |
Plate, fixation, bone - Product Code HRS
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Product | EVOS Screws - Product Usage: is a part of the EVOS MINI plating system, indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and small bone fragments. |
Code Information |
Part Numbers: 72424030, 72424010, 72424012, 72424016, 72424018, 72424020, 72424022, 72424024, 72434026, 72434028, 72434030, 72423014, 72423016, 72434065, 72434070, 72434075, 72412465, 72424032, 72424040, 72424055, 72424075, 72424080, 72423044. Batch/Lots: 14FM17199R, 14FM01226R, 14FM01227R, 14FM02610R, 14FM03418R, 14FM03420R, 14FM03422R, 14FM03424R, 14FM13578R, 14FM13580R, 14FM13581R, 14FM15166R, 14FM15167R, 14FM16225R, 14FM16228R, 14FM16229R, 14FM16386R, 14FM17201R, 14FM18527R, 14FM19218R, 14FM19226R, 14FM19229R, 14FM19360R. |
Recalling Firm/ Manufacturer |
Smith & Nephew, Inc. 1450 E Brooks Rd Memphis TN 38116-1804
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For Additional Information Contact | Garry Smith 901-396-2121 |
Manufacturer Reason for Recall | Multiple or incorrect expiration dates were provided on the affected designation labels. |
FDA Determined Cause 2 | Error in labeling |
Action | On August 24th the firm sent via email a notification to affected consignees. Consignees are asked to inspect inventory, locate and quarantine affected devices. Sales Reps and or distributors are instructed to notify customers of the field action and ensure required actions are complete. Affected product will be returned to Smith & Nephew. All consignees are asked to complete a Response Form, even if they do not have product to return. |
Quantity in Commerce | 71 units |
Distribution | International Distribution to the countries of Denmark, Sweden, France and Spain. |
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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