Tornier S.A.S.: Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthroplasty.

Hazard

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.

Details from the source

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 Quantity: 24 units Lot/code info: UDI/DI 03700434022926, Lot Numbers: 22A796, 22A797, 22A978, and 22A979

UPC codes

03700434022926

Source

Official record: FDA (Device enforcement) ↗

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