Recall Z-0125-2024— North Coast Medical Inc
Class II · Ongoing
Class II FDA medical device recall by North Coast Medical Inc, initiated 2023-08-18. FDA's recall record names no specific 510(k) clearance for this event. 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: The thumb strap of the wrist and thumb orthosis may contain latex that is not declared in the product labeling..
- Recalling firm
- North Coast Medical Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-08-18
- Firm location
- Morgan Hill, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.