Device product
Gladiator, Wrist & Thumb Orthosis, Part Numbers: NC86650 (Small/Left), NC86651 (Small/Right), NC86652 (Medium/Left), NC86653 (Medium/Right), NC86654 (Large/Left), NC86655 (Large/Right), NC86656 (X-Large/Left), and NC86657 (X-Large/Right)
Z-0125-2024
Product summary
- Event
- Event 93079
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 27 units
- Official record key
device-enforcement:Z-0125-2024
Official wording
Reason: The thumb strap of the wrist and thumb orthosis may contain latex that is not declared in the product labeling.
Code information: All Model Numbers without a manufacturing date on label
Distribution pattern: US: NC, CA, WI OUS: New Zealand, Australia,
Derived failure modes
-
Unknown
The thumb strap of the wrist and thumb orthosis may contain latex that is not declared in the product labeling.