Tornier recalls Stryker Blueprint Software versions 2.1.4 to 4.0.2 due to incompatible implant configurations that lack regulatory approval. Affected units have specific UDI-DI numbers.
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.
Tornier is recalling Stryker Blueprint Software versions 2.1.4 through 4.0.2 because the software can create implant configurations that aren't approved by regulators. This could lead to improper surgical planning if used without the correct regulatory clearance.
The software bug allows creating surgical plans for implant combinations that don't have regulatory approval. Using these incompatible configurations could lead to improper surgical outcomes if the software is used without the correct regulatory clearance.
Orthopedic surgeons and medical professionals using the software for joint replacement planning. Those who have the specific software versions or UDI-DI numbers listed are most at risk.
Check if you have Stryker Blueprint Software versions 2.1.4 to 4.0.2. Look for UDI-DI numbers: 03700434023114, 03700434023107, 03700434015065, or 03700434015058.
Verify your software version is between 2.1.4 and 4.0.2 inclusive.
Check for the specific UDI-DI numbers listed in the recall notice.
Versions 2.1.4 to 4.0.2 of Stryker Blueprint Software.
03700434023114, 03700434023107, 03700434015065, and 03700434015058.
The recall record does not specify a remedy.
We’ve drafted a message you can send Tornier to request your refund or repair — edit it as you like.
Subject: Recall Z-1883-2024 — Tornier Tornier Hello, I own a Tornier that is covered by recall Z-1883-2024 from Tornier. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.