Recall Z-2475-2020 ยท ITQ Joint, Knee, External Brace
Mueller Sports Medicine, Inc
Mueller Sports Medicine Hybrid Wraparound Knee Support, Qty: 1 unit per box
| Date | Jun 18, 2020 |
| Status | Terminated |
| Reason | Natural rubber is present in Hybrid Wraparound Knee Support labeled as "Not made with Natural Rubber latex". |
| Root cause | 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 Spo |
| Quantity | 135,354 units |
| Distribution | U.S. distribution only: AR and OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.