Recall Z-2240-2016— Biomet, Inc.

Name: FDA recall Z-2240-2016
Creator: U.S. Food and Drug Administration
Published: 2016-06-10

Class II · Terminated

Class II FDA medical device recall by Biomet, Inc., initiated 2016-06-10, terminated 2017-07-20. It names one FDA 510(k) clearance: K140018. 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. Reason: 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..

Recalling firm: Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-06-10
Terminated: 2017-07-20
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K140018 — TSP HIP FRACTURE PLATING SYSTEMBiomet, Inc.·cleared 2014-04-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.