Recalls / —
—#151016
Product
TENNIS ELBOW SUPPORT, PneuGel(TM), UNIVERSAL, REF 200A10, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis
- FDA product code
- IQI — Orthosis, Limb Brace
- Device class
- Class 1
- Medical specialty
- Physical Medicine
- Affected lot / code info
- Lots: 42249787, 42490802, 42737908, 42944296, 43000801, 43031421, 43036118, 43068890, 43134851, 4363109, and 43454441
Why it was recalled
DeRoyal received complaints of mold on Tennis Elbow Straps.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
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.
Recalling firm
- Firm
- DeRoyal Industries Inc
- Address
- 200 Debusk Ln, Powell, Tennessee 37849-4703
Distribution
- Distribution pattern
- US Nationwide Distribution
Timeline
- Recall initiated
- 2016-11-07
- Terminated
- 2022-01-13
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #151016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.