FDA Enforcement
Class II
Terminated
PNEUGEL(R) TENNIS ELBOW STRAP, UNIVERSAL, REF 12840000, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis
Recall: Z-0713-2017
·
Reported December 14, 2016
Enforcement
- Recall Number
- Z-0713-2017
- Event ID
- 75665
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- DeRoyal Industries Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 14, 2016
- Initiation Date
- November 7, 2016
- Classification Date
- December 6, 2016
- Termination Date
- January 13, 2022
- Address
- 200 Debusk Ln, N/A, Powell, TN, 37849-4703, United States
Description
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.
Code Info
Lots: 47001, 49894, and 51311
Distribution
US Nationwide Distribution
Quantity
791 units