Reported Oct 25, 2023 · Ongoing
Gladiator, Wrist & Thumb Orthosis, Part Numbers: NC86650 (Small/Left), NC86651 (Small/Right), NC86652 (Medium/Left),…
North Coast Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: North Coast Medical Inc · 135 E Main Ave Ste 110 · Morgan Hill, CA · 95037-7522
Is this the product you have?
- 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 codes and dates
- All Model Numbers without a manufacturing date on label
- Amount recalled
- 27 units
Where it was sold
Why it was recalled
The thumb strap of the wrist and thumb orthosis may contain latex that is not declared in the product labeling.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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