Recall Z-0125-2024 ยท ILH Splint, Hand, And Components
North Coast Medical Inc
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)
| Date | Oct 19, 2023 (initiated Aug 18, 2023) |
| Status | Open, Classified |
| Reason | The thumb strap of the wrist and thumb orthosis may contain latex that is not declared in the product labeling. |
| Root cause | Labeling mix-ups |
| Action | 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 ncmrecall@ncmedical.com 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. Rewo |
| Quantity | 27 units |
| Distribution | US: NC, CA, WI OUS: New Zealand, Australia, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.