Brand
IMRIS
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for IMRIS and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-01-14FDA-DeviceClass IIStop using affected IMRIS HFD100 devices
Torque screw may crack or separate. If used, an affected screw could lead to inadequate head stabilization, compromised surgical precision, procedural delays, requirement for alternate head fixation methods, and risk of patient injury.
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