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Terminated

TENNIS ELBOW SUPPORT, PneuGel(TM), UNIVERSAL, REF 200A10, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis

FDA Recall Z-0712-2017 · Posted None

Recalling FirmDeRoyal Industries Inc
Recall StatusTerminated
Product CodeIQI
Date Initiated2016-11-07
Date Terminated2022-01-13
Product Quantity56 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.

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