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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Blueprint

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 Class 2 Device Recall Stryker Blueprintsee related information
Date Initiated by FirmApril 16, 2024
Date PostedMay 22, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1883-2024
Recall Event ID 94444
510(K)NumberK211359 
Product Classification shoulder prosthesis, reverse configuration - Product Code PHX
ProductStryker Blueprint Software, Catalog #BPUE001.
Code Information Versions 2.1.4 to 4.0.2, UDI-DI numbers 03700434023114, 03700434023107, 03700434015065, and 03700434015058.
Recalling Firm/
Manufacturer		 Tornier S.A.S.
161 Rue Lavoisier
Montbonnot St Martin France
For Additional Information ContactMeghan Wells
901-201-9298
Manufacturer 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.
FDA Determined
Cause 2		Software change control
ActionThe 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.
DistributionUS Nationwide distribution in the states of FL, KY, NJ, and WI.
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.
510(K) Database510(K)s with Product Code = PHX
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