Z-0125-2024Class II

Gladiator, Wrist & Thumb Orthosis, Part Numbers: NC86650 (Small/Left), NC86651 (Small/Right), NC86652...

Name: Z-0125-2024 Gladiator, Wrist & Thumb Orthosis, Part Numbers: NC86650 (Small/Left), NC86651 (Small/Right), NC86652...
Creator: North Coast Medical Inc
Published: 2023-08-18
License: https://open.fda.gov/license/

North Coast Medical Inc / initiated 2023-08-18 / Open, Classified / root cause: labeling and UDI

FDA source

North Coast Medical Inc began a recall of Gladiator, Wrist & Thumb Orthosis, Part Numbers: NC86650 (Small/Left), NC86651 (Small/Right), NC86652 (Medium/Left), NC86653 (Medium/Right), NC86654... on 2023-08-18. FDA classified it as Class II and gives the reason as "The thumb strap of the wrist and thumb orthosis may contain latex that is not declared in the product labeling". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0125-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-18
Posted: 2023-10-19
Recalling firm: North Coast Medical Inc
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)
Product code: ILH Splint, Hand, And Components
Reason for recall: The thumb strap of the wrist and thumb orthosis may contain latex that is not declared in the product labeling.
Root cause tag: labeling and UDI
FDA 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 [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]
Quantity in commerce: 27 units
Distribution: US: NC, CA, WI OUS: New Zealand, Australia,
Product codes and lots: All Model Numbers without a manufacturing date on label

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0125-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0125-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-25	2023-10-19

Product code ILH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)