Summary
The FDA issued a Class II for Stryker Blueprint Software, Catalog #BPUE001. by Tornier S.A.S.. Reason: The software bug allows for case planning with anatomic glenoid Perform / Perform Augmented implants and anatomic humeral Tornier Flex implant configu.
Details
Source
Device Recall
External ID
Z-1883-2024
Action Date
2024-05-29
Status
Ongoing
Category
device
Product Description
Stryker Blueprint Software, Catalog #BPUE001.
Lot/Code Info: Versions 2.1.4 to 4.0.2, UDI-DI numbers 03700434023114, 03700434023107, 03700434015065, and 03700434015058.
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.
Distribution
US Nationwide distribution in the states of FL, KY, NJ, and WI.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-16
Company
Montbonnot St Martin
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 291 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Tornier S.A.S. has 15 FDA actions in our database, including 13 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Tornier S.A.S.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Tornier S.A.S. have FDA actions?
Tornier S.A.S. has 15 FDA actions in our database, including 13 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1883-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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