Biomet Recalls TSP Hip Fracture Plating System Due to Screw Fracture Risk
Biomet, Inc. is recalling 5,458 units of the TSP Hip Fracture Plating System because screws may fracture during implantation, potentially leaving a foreign body in the patient.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm (retained foreign body) where injury has not yet been reported, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Biomet, Inc. is recalling 5,458 units of the TSP Hip Fracture Plating System. The recall covers the device and associated instruments distributed worldwide, including the United States, Australia, The Netherlands, and Japan. The system is indicated for the open reduction and internal fixation of proximal femoral fractures.
The recall is due to a risk that the screw may fracture at the junction of the shaft and the head during implantation. If the fractured screw cannot be removed, the patient may retain a foreign body. The source text notes that soft tissue irritation will not occur because the retained portion of the screw is below the surface of the plate. A delay in surgery of less than 30 minutes may occur.
This recall is classified as Class II by the FDA. Healthcare providers should stop using the affected devices and contact Biomet, Inc. for further instructions.
The recalled product
- 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 intertrochante
- Manufacturer
- Biomet, Inc.
- Affected units
- 5,458
Distribution
Distributed nationwide across the United States.
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