Device evidence

device-recall:cfres:143880

Product 55 consists of all product under product code: HSB and same usage: Item no: 225900132 ONE-PIECE LAG SCREW 11MM 225900135 ONE-PIECE LAG SCREW 11MM 225900137 ONE-PIECE LAG SCREW 11MM 225900140 ONE-PIECE LAG SCREW 11MM 225900142 ONE-PIECE LAG SCREW 11MM 225900145 ONE-PIECE LAG SCREW 11MM 225900152 ONE-PIECE LAG SCREW 11MM Usage: An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

Official recall number

Z-1153-2016

Evidence summary

Product code: HSB
Recall status: Terminated
Event initiated: January 11, 2016
Root cause: Packaging
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-1153-2016