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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- Manufacturer
- Biomet, Inc.
- Affected units
- 5,458
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Biomet, Inc.
See all →- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assemblies Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12
- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assembly Recall for Packaging Damage
FDA (Devices) · 2026-08-12
Same hazard · screw fracture
See all →- HighAcumed Hexalob Screws Recalled for Risk of Fracture During Use
FDA (Devices) · 2026-07-01
Similar recalls
- HighZimmer Biomet Recalls THP Hip Plating System Due to Fracture Risk
FDA (Devices) · 2020-03-04
- HighBiomet Recalls HipLOC Hip Fracture Fixation System Plates Due to Fit Issues
FDA (Devices) · 2018-10-03
- HighBiomet Recalls HipLOC Hip Fracture Fixation System Plates
FDA (Devices) · 2018-10-03
- HighZimmer Biomet Recalls Affixus Hip Fracture Nails Due to Set Screw Malfunction
FDA (Devices) · 2018-11-21
- SevereZimmer Biomet Recalls Affixus Hip Fracture Nails Due to Set Screw Defect
FDA (Devices) · 2018-11-21
- HighZimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Issue
FDA (Devices) · 2018-11-21