Gladiator, Wrist & Thumb Orthosis, Part Numbers: NC86650 (Small/Left), NC86651 (Small/Right), NC86652 (Medium/Left), NC
Summary
The FDA issued a Class II for Gladiator, Wrist & Thumb Orthosis, Part Numbers: NC86650 (Small/Left), NC86651 by North Coast Medical Inc. Reason: The thumb strap of the wrist and thumb orthosis may contain latex that is not declared in the product labeling..
Details
Source
Device Recall
External ID
Z-0125-2024
Action Date
2023-10-25
Status
Ongoing
Category
device
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)
Lot/Code Info: All Model Numbers without a manufacturing date on label
Quantity Affected: 27 units
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,
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-18
Company
Morgan Hill, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 141 device recalls issued in the same week, part of 403 device-related FDA actions this month.
North Coast Medical Inc has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (North Coast Medical Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does North Coast Medical Inc have FDA actions?
North Coast Medical Inc has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0125-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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