Recall Z-0712-2017— DeRoyal Industries Inc
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: TENNIS ELBOW SUPPORT, PneuGel(TM), UNIVERSAL, REF 200A10, 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
TENNIS ELBOW SUPPORT, PneuGel(TM), UNIVERSAL, REF 200A10, 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.