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CurvaFix® Low Profile Implant
CURVAFIX, INC. · Model 7.5 mm x 130 mm · UDI-DI 10850070500293
HWC
Prescription
1
510(k) clearances
59,207
Adverse events (76 deaths)
389
Recalls
656
Facilities
Description
The CurvaFix Low Profile Implant is an implantable intramedullary device for pelvic fracture fixation. The devices have a threaded, self-tapping distal end and a driving torque interface at the proximal end. An integral shape lock feature changes the CurvaFix Implant from a flexible to rigid state after implantation. The CurvaFix Implant can be returned to a flexible state should device explant be required. Supplied individually on a backer card in a sterile barrier package placed in shelf carton. The device is manufactured from Stainless Steel.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-09-09 | In2bones USA, LLC | Due to labeling error, bone screws specified as fully threaded, are actually partially threaded screws. |
| 2026-04-24 | Medartis AG | The cannulation of the CCS screw is not centered. |
| 2026-01-23 | I.T.S. GmbH | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). |
| 2026-01-23 | I.T.S. GmbH | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). |
| 2026-01-09 | Medartis AG | Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws. |
| 2026-01-09 | Medartis AG | Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws. |
| 2025-11-24 | Smith & Nephew, Inc. | Removal of affected lot of screws due to labeling error. |
| 2024-04-12 | Medartis Inc. | Screw is 16mm long instead of 22mm long. |
| 2024-03-20 | Zimmer, Inc. | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user sinc |
| 2024-03-20 | Zimmer, Inc. | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user sinc |
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