Stryker Blueprint Surgical Planning Software Recall for Incompatible Implant Configurations
Stryker Blueprint Software versions 2.1.4 to 4.0.2 contain a bug allowing incompatible implant configurations without regulatory approval. The software was distributed nationwide in FL, KY, NJ, and WI.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a software defect that allows incompatible implant configurations without regulatory approval. No injuries or illnesses have been reported; however, the defect creates risk of surgical error through use of unapproved implant combinations.
Plain-English summary
Stryker Blueprint Software, version 2.1.4 through 4.0.2 (Catalog #BPUE001), manufactured by Tornier S.A.S., is being recalled. This software is used for surgical case planning and contains a bug that allows case planning with anatomic glenoid Perform and Perform Augmented implants combined with anatomic humeral Tornier Flex implants.
The implant combinations that the software allows are incompatible and do not have regulatory approval. These unapproved configurations were not authorized by the FDA for use together.
The affected software was distributed nationwide in Florida, Kentucky, New Jersey, and Wisconsin. Healthcare facilities and surgical teams in these states should be aware of this incompatibility issue.
The recalled product
- Product
- Stryker Blueprint Software, Catalog #BPUE001.
- Manufacturer
- Tornier S.A.S.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Versions 2.1.4 to 4.0.2
- UDI-DI numbers 03700434023114
- 03700434023107
- 03700434015065
- and 03700434015058.
Distribution
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