Z-0125-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 25, 2023
- Initiation Date
- August 18, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27 units
Product Description
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)
Reason for Recall
The thumb strap of the wrist and thumb orthosis may contain latex that is not declared in the product labeling.
Distribution Pattern
US: NC, CA, WI OUS: New Zealand, Australia,
Code Information
All Model Numbers without a manufacturing date on label