Device product
TENNIS ELBOW SUPPORT, PneuGel(TM), UNIVERSAL, REF 200A10, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis
Z-0712-2017
Product summary
- Event
- Event 75665
- Status
- Terminated
- Classification
- Class II
- Quantity
- 56 units
- Official record key
device-enforcement:Z-0712-2017
Official wording
Reason: DeRoyal received complaints of mold on Tennis Elbow Straps.
Code information: Lots: 42249787, 42490802, 42737908, 42944296, 43000801, 43031421, 43036118, 43068890, 43134851, 4363109, and 43454441
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
DeRoyal received complaints of mold on Tennis Elbow Straps.