PlainRecalls
FDA Devices Moderate Class II Terminated

PNEUGEL(R) TENNIS ELBOW STRAP, UNIVERSAL, REF 12840000, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis

Reported: December 14, 2016 Initiated: November 7, 2016 #Z-0713-2017

Product Description

PNEUGEL(R) TENNIS ELBOW STRAP, UNIVERSAL, REF 12840000, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis

Reason for Recall

DeRoyal received complaints of mold on Tennis Elbow Straps.

Details

Recalling Firm
DeRoyal Industries Inc
Units Affected
791 units
Distribution
US Nationwide Distribution
Location
Powell, TN

Frequently Asked Questions

What product was recalled?
PNEUGEL(R) TENNIS ELBOW STRAP, UNIVERSAL, REF 12840000, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis. Recalled by DeRoyal Industries Inc. Units affected: 791 units.
Why was this product recalled?
DeRoyal received complaints of mold on Tennis Elbow Straps.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 14, 2016. Severity: Moderate. Recall number: Z-0713-2017.