Stryker Blueprint Software (Tornier) – case planning bug (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Stryker Blueprint Software, Catalog #BPUE001.
Brand
Tornier S.A.S. 161 Rue Lavoisier Montbonnot St Martin France
Lot Codes / Batch Numbers
Versions 2.1.4 to 4.0.2, UDI-DI numbers 03700434023114, 03700434023107, 03700434015065, and 03700434015058.
Products Sold
Versions 2.1.4 to 4.0.2, UDI-DI numbers 03700434023114, 03700434023107, 03700434015065, and 03700434015058.
Tornier S.A.S. 161 Rue Lavoisier Montbonnot St Martin France is recalling Stryker Blueprint Software, Catalog #BPUE001. due to The software bug allows for case planning with anatomic glenoid Perform / Perform Augmented implants and anatomic humeral Tornier Flex implant configu. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026