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Blueprint recallZ-1883-2024 · Tornier S.A.S. · initiated Apr 16, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Tornier S.A.S. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Software change control

What the company is doing

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 [email protected].

Recall details

Recall number
Z-1883-2024
Status
Open, Classified
Initiated by the company
Apr 16, 2024
Posted by the FDA
May 22, 2024
Recalling firm
Tornier S.A.S.
Product code
PHX
FDA submissions
K211359
Distribution
US Nationwide distribution in the states of FL, KY, NJ, and WI.

Product description

Stryker Blueprint Software, Catalog #BPUE001.

Code information (models, lots, serial numbers)

Versions 2.1.4 to 4.0.2, UDI-DI numbers 03700434023114, 03700434023107, 03700434015065, and 03700434015058.

Devices named in this recall

4 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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