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U.S. Department of Health and Human Services

Class 2 Device Recall Smith & Nephew EVOS screws

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  Class 2 Device Recall Smith & Nephew EVOS screws see related information
Date Initiated by Firm October 25, 2021
Create Date November 18, 2021
Recall Status1 Open3, Classified
Recall Number Z-0265-2022
Recall Event ID 88975
510(K)Number K162078  
Product Classification Plate, fixation, bone - Product Code HRS
Product Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM. Sterile.
Code Information REF 72413575 - batch #21FM24289; REF 72413570 - batch #21GM04743.
Recalling Firm/
Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information Contact Mr. Dave Snyder
Manufacturer Reason
for Recall
The labels on the packages of screws were switched.
FDA Determined
Cause 2
Error in labeling
Action The recalling firm issued letters dated 10/25/2021 on the same day via email and FedEx overnight. The letter explained the issue and the potential risk of use of the product. Required actions were listed on the enclosed response form. The actions included inspecting their inventory and quarantining the affected product immediately and returning it. Distributors or sales representatives were to notify their customers of the field action and ensure the required actions are complete.
Quantity in Commerce 224 units
Distribution Distribution was made to AL, AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, ME, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TN, TX, and WA. There was no direct government distribution. There was no military distribution. Foreign distribution was made to Australia, Canada, China, Dubai/MENA, Germany, Italy, Japan, Netherlands, Singapore, and Thailand.
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.