Z-1883-2024Class II

Stryker Blueprint Software, Catalog #BPUE001

Name: Z-1883-2024 Stryker Blueprint Software, Catalog #BPUE001
Creator: Tornier S.A.S.
Published: 2024-04-16
License: https://open.fda.gov/license/

Tornier S.A.S. / initiated 2024-04-16 / Open, Classified / root cause: software

FDA source

Tornier S.A.S. began a recall of Stryker Blueprint Software, Catalog #BPUE001 on 2024-04-16. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1883-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-16
Posted: 2024-05-22
Recalling firm: Tornier S.A.S.
Product: Stryker Blueprint Software, Catalog #BPUE001.
Product code: PHX Shoulder Prosthesis, Reverse Configuration
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.
Root cause tag: software
FDA root cause: Software change control
Action: 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].
Distribution: US Nationwide distribution in the states of FL, KY, NJ, and WI.
Product codes and lots: Versions 2.1.4 to 4.0.2, UDI-DI numbers 03700434023114, 03700434023107, 03700434015065, and 03700434015058.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1883-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1883-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-29	2024-05-22

Product code PHX

K211359Class IITornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific InstrumentationTornier, Inc. / cleared 2021-11-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)