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CAPTURE™ High Torque Screw System

Ascension Orthopedics, Inc. · Model HITORQ45IMP · UDI-DI 10381780064541

HWC Prescription

510(k) clearances

59,207

Adverse events (76 deaths)

389

Recalls

656

Facilities

Description

The Capture High-Torque Screw System consists of various sizes of cannulated screws. The screws are machined, metallic screws with a cannulation that are self-drilling and self-tapping. Each type is offered in a variety of diameters and lengths and is manufactured from stainless steel and titanium. The system is intended for fixation of fractures in long bones, fixation of small bones, arthrodesis of the foot, wrist and elbow, and small and long bone osteotomies. This particular system consists of 4.0mm and 5.0mm screws. Instruments are provided to assist with the implants.

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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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.