Recall Z-0713-2017— DeRoyal Industries Inc

Name: FDA recall Z-0713-2017
Creator: U.S. Food and Drug Administration
Published: 2016-11-07

Class II · Terminated

Class II FDA medical device recall by DeRoyal Industries Inc, initiated 2016-11-07, terminated 2022-01-13. FDA's recall record names no specific 510(k) clearance for this event. Product: PNEUGEL(R) TENNIS ELBOW STRAP, UNIVERSAL, REF 12840000, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis. Reason: DeRoyal received complaints of mold on Tennis Elbow Straps..

Recalling firm: DeRoyal Industries Inc
Classification: Class II
Status: Terminated
Initiated: 2016-11-07
Terminated: 2022-01-13
Firm location: Powell, TN, United States

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.