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U.S. Department of Health and Human Services

Class 2 Device Recall Gladiator, Wrist & Thumb Orthosis

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 Class 2 Device Recall Gladiator, Wrist & Thumb Orthosissee related information
Date Initiated by FirmAugust 18, 2023
Date PostedOctober 19, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0125-2024
Recall Event ID 93079
Product Classification Splint, hand, and components - Product Code ILH
ProductGladiator, 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)
Code Information All Model Numbers without a manufacturing date on label
FEI Number 1000124207
Recalling Firm/
Manufacturer		 North Coast Medical Inc
135 E Main Ave Ste 110
Morgan Hill CA 95037-7522
For Additional Information ContactCustomer Service
800-821-9319
Manufacturer Reason
for Recall		The thumb strap of the wrist and thumb orthosis may contain latex that is not declared in the product labeling.
FDA Determined
Cause 2		Labeling mix-ups
ActionOn 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 in Commerce27 units
DistributionUS: NC, CA, WI OUS: New Zealand, Australia,
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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