Stryker Blueprint Software, Catalog #BPUE001.
- Recall Initiated
- April 16, 2024
- Posted
- May 22, 2024
- Recall Number
- Z-1883-2024
Reason for Recall
The software bug allows for case planning with anatomic glenoid Perform / Perform Augmented implants and anatomic humeral Tornier Flex implant configurations that are incompatible and do not have regulatory approval.
Distribution
US Nationwide distribution in the states of FL, KY, NJ, and WI.
Lot / Code Info
Versions 2.1.4 to 4.0.2, UDI-DI numbers 03700434023114, 03700434023107, 03700434015065, and 03700434015058.
Root Cause
Software change control
Action Taken
The firm issued letters via email on 4/16/2024. The email provided the issue and risks and said that for additional information regarding risks, exact incompatible configuration details, and steps for you to take, please refer to the attached document. The email listed a requested action, which was to review the case information provided on the business acknowledgment form, confirm the final implants used in this surgery, and complete and sign the response form on Page 4 at their earliest convenience. The attached Urgent Medical Device Recall letter was dated 16-April-2024 and provided the product affected, product description, product issue, potential risks, and actions needed by customers and distributors. Those actions included: 1. Review the case information provided on the business acknowledgment form and confirm the final implants used in this surgery. Return the enclosed business reply form by email to confirm receipt and understanding of this notice. 2. A software patch, Version 4.1.1, is currently in development and is scheduled for release by April 16, 2024. This software patch will resolve this issue and prevent the selection of these incompatible implants. 3. Please ensure that all potential users of these products within your facility are made aware of this notification and instruct all potential users to reference this notice prior to use. 4. Maintain awareness of this communication internally until all required actions have been completed within your facility. 5. Please inform us of any adverse event and/or report them to the Health/Competent Authorities in accordance with current regulations. For questions or concerns, please contact memphis.fieldaction@stryker.com.