FDA Medical Device Recalls (openFDA)
Mueller Sports Medicine, Inc: Mueller Sports Medicine Hybrid Wraparound Knee Support, Qty: 1 unit per box
- Recall number
- Z-2475-2020
- Recalling firm
- Mueller Sports Medicine, Inc
- Product
- Mueller Sports Medicine Hybrid Wraparound Knee Support, Qty: 1 unit per box
- Status
- Terminated
- Initiated
- 2020-06-18
- Posted
- not on file
- Terminated
- 2021-10-29
- 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 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
- 135,354 units
- Distribution
- U.S. distribution only: AR and OH.
- Lot, serial or model codes
- Reference number: 64217, UPC number: 074676642178
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ITQ
- Firm FEI
- 2110420
- Firm city
- Prairie Du Sac
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28