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2.7mm T10 Drive Bypass Cortical Locking Screw, 14mm

TOBY ORTHOPAEDICS · Model NA · UDI-DI 00816101017751

HWC

510(k) clearances

58,622

Adverse events (75 deaths)

388

Recalls

655

Facilities

Description

The titanium alloy bypass locking screws (torx T-10 head) are designed to affix the plate to the bone using a similar design as the cortical locking screw, except that the screw head includes scallops that allow a second locking screw to be installed in the adjacent hole. The bypass locking screws are 2.7mm in diameter and are available in multiple lengths ranging from 10mm to 34mm

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

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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.