Stryker Blueprint Glenoid Pin Guide May Disassemble During Shoulder Surgery
The metal tube of the Stryker Blueprint Glenoid Pin Guide may disassemble from the plastic handle. This can prevent the guidance system from detecting the device, potentially prolonging surgery or requiring a switch to conventional surgical methods.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall of a surgical guidance device with no reported injuries or illnesses. The hazard involves a functional defect where the device may fail intraoperatively, potentially compromising surgical guidance. This qualifies as a risk-of-harm product where injury has not yet been reported, meeting the High severity criterion.
Plain-English summary
Tornier S.A.S. is recalling the Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide (REF MRUE200), which is used during total shoulder arthroplasty (shoulder replacement surgery). The device is part of a mixed reality surgical guidance system. The recall affects 24 units distributed in the United States (Minnesota, Kentucky, Maryland, Massachusetts, Texas, Alaska, and Idaho) as well as France and Canada.
The metal tube of the Pin Guide may disassemble from the plastic handle. When this occurs, the mixed reality headset cannot detect the Pin Guide, compromising its function as a surgical guidance tool.
As a result, surgeons may experience prolonged surgery time or be forced to switch from the guided surgical method to conventional (non-guided) surgical techniques.
Healthcare facilities with affected lots (22A796, 22A797, 22A978, and 22A979, identified by UDI/DI 03700434022926) should immediately discontinue use of these devices and contact the manufacturer for further guidance.
The recalled product
- Product
- Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthroplasty.
- Manufacturer
- Tornier S.A.S.
- Hazard
- assembly-failure
- device-malfunction
- surgical-guidance-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- UDI/DI 03700434022926
- Lot Numbers: 22A796
- 22A797
- 22A978
- and 22A979
Distribution
Distributed in 7 states:
- AK
- ID
- KY
- MA
- MD
- MN
- TX
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