Home › Bradshaw Medical, Inc. › TORO, MEDIUM AXIAL, 3.5mm HEX

TORO, MEDIUM AXIAL, 3.5mm HEX

Bradshaw Medical, Inc. · Model 804-06-009 · UDI-DI 00810019933066

HWR Prescription

510(k) clearances

9,892

Adverse events (1 deaths)

Recalls

176

Facilities

Description

A non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Recalls

Date	Firm	Reason
2016-01-05	Biomet U.K., Ltd.	Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to pro
2016-01-05	Biomet U.K., Ltd.	Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to pro
2013-04-04	Smith & Nephew, Inc., Endoscopy Div.	Driver does not meet specification, oversized. Driver may not be able to be fully inserted into the screw, or screw may become stuck on the driver.
2010-01-15	Biomet Microfixation, Inc.	The patient Distractor Driver, used in Osteotomy procedures, may not ratchet and advance the distraction device as intended. If the distraction device does not advance, bone cons
2007-10-10	Pioneer Surgical Technology	The pins may come out of the instrument and, if this happens, they could fall into/remain in the patient.
2007-10-04	Wright Medical Technology Inc	Breakage: breaking of the connecting foot that is on the distal surface of the instrument

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.