medical MODERATE Updated 2024-05-29

Tornier S.A.S. recalls Stryker Blueprint Software, Catalog #BPUE001.

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Recalled Product

Stryker Blueprint Software, Catalog #BPUE001.

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Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Versions 2.1.4 to 4.0.2, UDI-DI numbers 03700434023114, 03700434023107, 03700434015065, and 03700434015058.

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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