Device product
PNEUGEL(R) TENNIS ELBOW STRAP, UNIVERSAL, REF 12840000, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis
Z-0713-2017
Product summary
- Event
- Event 75665
- Status
- Terminated
- Classification
- Class II
- Quantity
- 791 units
- Official record key
device-enforcement:Z-0713-2017
Official wording
Reason: DeRoyal received complaints of mold on Tennis Elbow Straps.
Code information: Lots: 47001, 49894, and 51311
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
DeRoyal received complaints of mold on Tennis Elbow Straps.