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U.S. Department of Health and Human Services

Class 2 Device Recall Mueller Sports Medicine Hybrid Wraparound Knee Support

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 Class 2 Device Recall Mueller Sports Medicine Hybrid Wraparound Knee Supportsee related information
Date Initiated by FirmJune 18, 2020
Create DateJune 30, 2020
Recall Status1 Terminated 3 on October 29, 2021
Recall NumberZ-2475-2020
Recall Event ID 85884
Product Classification Joint, knee, external brace - Product Code ITQ
ProductMueller Sports Medicine Hybrid Wraparound Knee Support, Qty: 1 unit per box
Code Information Reference number: 64217, UPC number: 074676642178
FEI Number 2110420
Recalling Firm/
Manufacturer		 Mueller Sports Medicine, Inc
1 Quench Dr
Prairie Du Sac WI 53578-2100
For Additional Information Contact
800-356-9522
Manufacturer Reason
for Recall		Natural rubber is present in Hybrid Wraparound Knee Support labeled as "Not made with Natural Rubber latex".
FDA Determined
Cause 2		Process change control
ActionMueller 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 Commerce135,354 units
DistributionU.S. distribution only: AR and OH.
Total Product Life CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
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