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I.CO.S®

NEWDEAL · Model 119566ND · UDI-DI 10381780052159

HXX Prescription

510(k) clearances

23,401

Adverse events (4 deaths)

Recalls

465

Facilities

Description

The cannulated external screwdriver is used to achieve additional dynamic compression by advancing the outer thread head screw independently of its main body. The body (internal part) of the 6.5mm compression screw will not be moved. It has a specific spanner slotted-like tip with two threads opposite each other designed to fit the screw head.

Recalls

Date	Firm	Reason
2024-04-25	Synthes (USA) Products LLC	Stardrive Screwdrivers manufactured without a 5-degree relief cut around the tip and will not engage with their respective 1.3mm and 1.5mm screws, may result in surgical delay
2021-10-25	Aesculap Implant Systems LLC	Set screwdriver fails during surgery by deforming at the tip during engagement and manipulation of the implant.
2021-04-15	Flower Orthopedics Corporation	Cannulated Screwdrivers may break at the driver tip along the shaft, near the handle extending surgery time and additional x-ray to identify the fragments from the breakages
2019-05-28	Zimmer Biomet, Inc.	There is a potential for weak seals of the sterile packaging.
2019-03-14	Trilliant Surgical, LLC	A screwdriver used to facilitate implant insertion and removal was found to be out of specification for the minor diameter of the drive feature causing the driver to be unable to r
2018-05-04	Synthes (USA) Products LLC	The adapter may demonstrate a degradation of function as the final products were assembled with ball bearings of high carbon content that is likely to rust prematurely.
2016-04-27	Orthofix, Inc	There is a possibility that the subject set screw driver could disengage from the torque limiting handle when the counter torque wrench is allowed to contact the counter torque han
2016-04-26	Greatbatch Medical	Greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Greatbatch identified through laboratory testing that the required sterility assurance level (SA
2014-05-15	Ebi, Llc	The Cypher MIS Screw Inserter may exhibit an increased rate of instrument tip failure.
2014-01-03	Medtronic Sofamor Danek USA Inc	The retaining tabs component of the Set Screw Retaining Drive may be oversized, which will not allow proper mating between the Set Screw Retaining Drive and the set screw.

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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.