FDA Device recall Z-2240-2016
TSP Hip Fracture Plating System device, fixation, proximal femoral, implant The Biomet Hip Fracture Plating Systems are indicated for use i…
- FDA Device
- Class II
- terminated
- Published 2016-07-27
On 2016-07-27 the FDA classified a Class II recall of TSP Hip Fracture Plating System device, fixation, proximal femoral, implant The Biomet Hip Fracture Plating Systems are indicated for use i… by Biomet, citing 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 i….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2240-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-06-10 |
| Published | 2016-07-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Biomet |
| Distribution | US |
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.
Identifiers
| code_info | All Lots. Part Number / Description: 14-451002 130 DEG 2-HOLE LEFT NECK FX 14-451004 130 DEG 4-HOLE LEFT NECK…All Lots. Part Number / Description: 14-451002 130 DEG 2-HOLE LEFT NECK FX 14-451004 130 DEG 4-HOLE LEFT NECK FX 14-451070 7.5MM TELESCOPE LAG SCR 70MM 14-451075 7.5MM TELESCOPE LAG SCR 75MM 14-451080 7.5MM TELESCOPE LAG SCR 80MM 14-451085 7.5MM TELESCOPE LAG SCR 85MM 14-451090 7.5MM TELESCOPE LAG SCR 90MM 14-451095 7.5MM TELESCOPE LAG SCR 95MM 14-451100 7.5MM TELESCOPE LAG SCR 100MM 14-451102 130 DEG 2-HOLE RIGHT NECK FX 14-451104 130 DEG 4-HOLE RIGHT NECK FX 14-451105 7.5MM TELESCOPE LAG SCR 105MM 14-451110 7.5MM TELESCOPE LAG SCR 110MM 14-451115 7.5MM TELESCOPE LAG SCR 115MM 14-451120 7.5MM TELESCOPE LAG SCR 120MM 14-451125 7.5MM TELESCOPE LAG SCR 125MM 14-451130 7.5MM TELESCOPE LAG SCR 130MM 14-451500 ANGLE GUIDE 130 DEG 14-451502 GUIDE WIRE 3.0MM 14-451503 GUIDE PIN DRIVER 3.0MM 14-451504 TARGETING GUIDE 130 DEG LEFT 14-451505 TARGETING GUIDE 130 DEG RIGHT 14-451509 JIG ATTACHMENT DRIVER 3.5MM 14-451510 NON-LOCK GUIDE SLEEVE 7.5 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2240-2016%22
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