Company: Tornier S.A.S.
Date of Enforcement Report: 4/8/2025
Class II
PRODUCT
stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty.
Recall Number:
Z-1536-2025
REASON:
Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.
RECALLING FIRM/MANUFACTURER:
Tornier S.A.S.
VOLUME:
20 units
DISTRIBUTION:
US: TX, MN, AK, PA, MA, TN, ID, and France, Canada, and Ireland
