Recall Z-1541-2025— Tornier S.A.S.
Class II · Ongoing
Class II FDA medical device recall by Tornier S.A.S., initiated 2025-03-05. It names one FDA 510(k) clearance: K222510. Product: stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty. 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
- Tornier S.A.S.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-03-05
- Firm location
- Montbonnot-Saint-Martin, N/A, France
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.