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Class 2 Device Recall Mueller Sports Medicine Hybrid Wraparound Knee Support |
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Date Initiated by Firm |
June 18, 2020 |
Create Date |
June 30, 2020 |
Recall Status1 |
Terminated 3 on October 29, 2021 |
Recall Number |
Z-2475-2020 |
Recall Event ID |
85884 |
Product Classification |
Joint, knee, external brace - Product Code ITQ
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Product |
Mueller Sports Medicine Hybrid Wraparound Knee Support, Qty: 1 unit per box |
Code Information |
Reference number: 64217, UPC number: 074676642178 |
Recalling Firm/ Manufacturer |
Mueller Sports Medicine, Inc 1 Quench Dr Prairie Du Sac WI 53578-2100
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For Additional Information Contact |
800-356-9522
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Manufacturer Reason for Recall |
Natural rubber is present in Hybrid Wraparound Knee Support labeled as "Not made with Natural Rubber latex".
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FDA Determined Cause 2 |
Process change control |
Action |
Mueller Sports sent notification letters to both customers and distributors dated, 6/12/2020, and titled, "URGENT MEDICAL DEVICE RECALL". The letter indicate that Natural Rubber was present in the Hybrid Wraparound Knee Support and the product is labeled with the statement: Not made with Natural Rubber Latex. The firm initiated a voluntary recall and is notifying customers of the issue. Customers should immediately discontinue use of any product identified in the letter. If customers have affected product, they need to complete the enclosed Recall Acknowledgment Form and fax to Mueller Sports Medicine at 1-800-852-4334 Attention Recall. Once the fax is received, the firm will provide instructions on how to return or dispose of the affected product. |
Quantity in Commerce |
135,354 units |
Distribution |
U.S. distribution only: AR and OH. |
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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