Biomet, Inc. recalls TSP Hip Fracture Plating System device, fixation, proximal femoral, implant The Biomet Hip Fracture Plating Systems are…

Recall date

June 10, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2240-2016

FDA classification

Class II

Brand / firm

Biomet, Inc.

Sold / distributed

Worldwide Distribution - US (Nationwide) Internationally to Australia, The Netherlands, and Japan

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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