Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 301–312 of 386 recalls
Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.
There is a potential for improper crimps on the signal wires of the actuators which could result in a loss of ability to lower the bed or the foot section of the bed.
The high voltage capacitor may fail early in the product life cycle after delivery of surge voltages. When this failure occurs, the capacitor may produce smoke and a burning smell.…
An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.
An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.
An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.
Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing.
The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
Devices for the affected lot were not assembled according to product specifications. The distraction rod outer diameter was assembled with a 5.5mm rod versus the required 5.0mm.