FDA recall Z-0125-2024

North Coast Medical Inc · Class II · 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)

Reason for recall

The thumb strap of the wrist and thumb orthosis may contain latex that is not declared in the product labeling.

Distribution

US: NC, CA, WI OUS: New Zealand, Australia,

Key facts

Status
Ongoing
Initiation date
2023-08-18
Report date
2023-10-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Morgan Hill, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0125-2024