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U.S. Department of Health and Human Services

Class 2 Device Recall My3D Personalized Solutions Humeral Cup

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 Class 2 Device Recall My3D Personalized Solutions Humeral Cupsee related information
Date Initiated by FirmMay 20, 2025
Date PostedJune 27, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2042-2025
Recall Event ID 97005
Product Classification Total shoulder arthroplasty system - Product Code QHQ
ProductMy3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device
Code Information Model Number: C24-0223-0003. UDI-DI #: N/A. Serial #: C24-0223
FEI Number 3013450937
Recalling Firm/
Manufacturer		 Onkos Surgical, Inc.
77 E Halsey Rd
Parsippany NJ 07054-3714
For Additional Information ContactSean Curry
973-264-5400
Manufacturer Reason
for Recall		Required inspections were not performed on finished product prior to release and distribution.
FDA Determined
Cause 2		Process control
ActionThe firm notified the single customer via telephone call on 05/20/2025 and it was followed up with a letter emailed on 05/29/2025. The notification instructed the customer to segregate and quarantine the component immediately and return the implant component in question within 2 business days of acknowledgment of notification. The component was returned on 05/22/2025. Distributors have responsibility for maintaining field inventory and are responsible for the inventory, even if located on site at a hospital as the products are not purchased/owned by the hospital or patient prior to implantation.
Quantity in Commerce1 unit
DistributionUS Nationwide distribution in the state of Maryland.
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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