Z-2475-2020Class II

Mueller Sports Medicine Hybrid Wraparound Knee Support, Qty: 1 unit per box

Name: Z-2475-2020 Mueller Sports Medicine Hybrid Wraparound Knee Support, Qty: 1 unit per box
Creator: Mueller Sports Medicine, Inc
Published: 2020-06-18
License: https://open.fda.gov/license/

Mueller Sports Medicine, Inc / initiated 2020-06-18 / Terminated / root cause: labeling and UDI

FDA source

Mueller Sports Medicine, Inc began a recall of Mueller Sports Medicine Hybrid Wraparound Knee Support, Qty: 1 unit per box on 2020-06-18. FDA classified it as Class II and gives the reason as "Natural rubber is present in Hybrid Wraparound Knee Support labeled as "Not made with Natural Rubber latex"". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2475-2020
Classification: Class II
Status: Terminated
Initiated: 2020-06-18
Posted: 2020-06-30
Terminated: 2021-10-29
Recalling firm: Mueller Sports Medicine, Inc
Product: Mueller Sports Medicine Hybrid Wraparound Knee Support, Qty: 1 unit per box
Product code: ITQ Joint, Knee, External Brace
Reason for recall: Natural rubber is present in Hybrid Wraparound Knee Support labeled as "Not made with Natural Rubber latex".
Root cause tag: labeling and UDI
FDA 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 in commerce: 135,354 units
Distribution: U.S. distribution only: AR and OH.
Product codes and lots: Reference number: 64217, UPC number: 074676642178

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2475-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2475-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-30

Product code ITQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)