FDA Medical Device Recalls (openFDA)
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)
- Recall number
- Z-0125-2024
- 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)
- Status
- Open, Classified
- Initiated
- 2023-08-18
- Posted
- 2023-10-19
- Terminated
- not on file
- 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. 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: NCMRecall@ncmedical.com
- Quantity
- 27 units
- Distribution
- US: NC, CA, WI OUS: New Zealand, Australia,
- Lot, serial or model codes
- All Model Numbers without a manufacturing date on label
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ILH
- Firm FEI
- 1000124207
- Firm city
- Morgan Hill
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28