Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthro
Summary
The FDA issued a Class II for Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indica by Tornier S.A.S.. Reason: The Pin Guide is being recalled because the metal tube may disassemble from the plastic handle. This can result in the Blueprint Mixed Reality headset.
Details
Source
Device Recall
External ID
Z-0846-2025
Action Date
2025-01-22
Status
Ongoing
Category
device
Product Description
Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthroplasty.
Lot/Code Info: UDI/DI 03700434022926, Lot Numbers: 22A796, 22A797, 22A978, and 22A979
Quantity Affected: 24 units
Reason for Recall
The Pin Guide is being recalled because the metal tube may disassemble from the plastic handle. This can result in the Blueprint Mixed Reality headset being unable to detect the Pin Guide and potentially prolonging surgery time or changing of surgical method from guided to conventional.
Distribution
US: MN, KY, MD, MA, TX, AK, TX, ID; France, Canada
Type: Voluntary: Firm initiated
Recall Initiated: 2024-12-18
Company
Montbonnot-Saint-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 249 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-0846-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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