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)

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

On September 15, 2023, North Coast Medical issued a "Urgent Medical Device Correction" notification via Email and First Class Mail Letter. North Coast Medical ask consignees to take the following actions: 1. Inventory Check: Please check your inventory for the item number referenced on your invoice. 2. Quarantine: If you identify the affected unit(s), please quarantine them pending label correction & contact [email protected] or 1 800 821 9319. If the product is no longer in your possession or has been disposed of, please go to Step 4 and complete the Acknowledgement Form. 3. Rework: We will ship the correct label to be placed on the box per the Rework Instructions & Acknowledgement Form. 4. Document: Once the product has been relabeled per the Rework Instructions, complete the Acknowledgement Form for reporting to North Coast Medical, Inc. 5. In addition, if you have distributed this product to another individual, please identify and immediately notify your customers of this product correction. If you have any questions concerning this communication, please don t hesitate to contact your Sales Representative or other support as noted below: P: 1 800 821 9319, Monday - Friday 8:00AM-5:00PM (PST) E: [email protected]