Home › Ascension Orthopedics, Inc. › CAPTURE™ High Torque Screw System

CAPTURE™ High Torque Screw System

Ascension Orthopedics, Inc. · Model CSS50000025024T · UDI-DI 10381780122326

HWC Prescription

510(k) clearances

58,622

Adverse events (75 deaths)

388

Recalls

655

Facilities

Description

Cannulated screw is a machined, metallic screw that is manufactured from stainless steel and titanium with a cannulation that is self-drilling and self-tapping. The CAPTURE High-Torque Screw is intended for fixation of the pelvis and illiosacral join, as well as fixations of fractures and osteotomies in long and small bones, including those in the foot, patella, ankle, wrist, and elbow. Intended for use correction Arthrodesis of the foot, wrist and elbow.

Recalls

Date	Firm	Reason
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
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

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

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.