PNEUGEL(R) TENNIS ELBOW STRAP, UNIVERSAL, REF 12840000, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis
FDA Recall Z-0713-2017 · Posted None
Recalling FirmDeRoyal Industries Inc
Recall StatusTerminated
Product CodeIQI
Date Initiated2016-11-07
Date Terminated2022-01-13
Product Quantity791 units
Reason for Recall
DeRoyal received complaints of mold on Tennis Elbow Straps.
Firm Action
DeRoyal issued their recall on 11/7/16 to the physician / clinician level by sending recall letters to its direct accounts and sales representatives. The foreign customer was notified by email on 11/7/2016. The customers were asked to identify the affected products, destroy them and return the provided notice of destruction form to DeRoyal for credit.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide Distribution
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.