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Biomet, Inc. recalls TSP Hip Fracture Plating System device, fixation, proximal femoral, implant The Biomet Hip Fracture Plating Systems ar
Recalled July 27, 2016 · FDA recall Z-2240-2016 · Biomet
Hazard
The screw may fracture at the junction of the shaft and the head during implantation. The patient may retain a foreign body if the fractured screw cannot be removed. Soft tissue irritation will not occur as the retained portion of the screw is below the surface of the plate. A delay in surgery less than 30 minutes may occur. · FDA Class II
Units
5458 units
Sold at
Worldwide Distribution - US (Nationwide) Internationally to Australia, The Netherlands, and Japan
Description
The screw may fracture at the junction of the shaft and the head during implantation. The patient may retain a foreign body if the fractured screw cannot be removed. Soft tissue irritation will not occur as the retained portion of the screw is below the surface of the plate. A delay in surgery less than 30 minutes may occur.
Product
TSP Hip Fracture Plating System device, fixation, proximal femoral, implant The Biomet Hip Fracture Plating Systems are indicated for use in the open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures and intertrochanteric fractures. Fracture plates with six or more femoral shaft fixation screw holes are also indicated for subtrochanteric fractures as well as proximal femoral osteotomies
Manufacturer(s)
Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →