Tornier S.A.S.: stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder Arthroplasty

Hazard

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.

Details from the source

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. Distribution: US: TX, MN, AK, PA, MA, TN, ID, and France, Canada, and Ireland Quantity: 14 Lot/code info: GTIN 03700434016505

UPC codes

03700434016505

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.