| Class 2 Device Recall Smith & Nephew EVOS screws | |
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
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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/ Manufacturer |
Smith & Nephew, Inc. 1450 E Brooks Rd Memphis TN 38116-1804
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For Additional Information Contact | Mr. Dave Snyder 978-749-1440 |
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 |
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = HRS
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