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Screwdriver
FDA product code HXX · Class 1 · Orthopedic
0
Registered devices
23,582
Adverse events
32
Recalls
4
510(k) clearances
Devices with this code
Tecomet — TECOMET INC.PSS System — PRECISION SPINE, INC.Dyna Locking Trochanteric Nail — CG MedTech Co.,Ltd.TriLeap Lower Extremity Anatomic Plating System — CROSSROADS EXTREMITY SYSTEMSPERLA ® TL — SpineArt SAGeneral Instrument — ALPHATEC SPINE, INC.GENERIC Surgical Instruments — CTL Medical CorporationMedtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC.Tiger — Trilliant Surgical, LLCSilverton Spinal Fixation System — Highridge Medical, LLCNA — Synthes GmbHBradshaw Medical Inc. — Bradshaw Medical, Inc.WishBox — Wishbone Medical, Inc.NA — Synthes GmbHNA — Synthes GmbHVu a-POD Prime NanoMetalene — Seaspine Orthopedics CorporationCUSTOM — MEDICREA INTERNATIONALNA — Synthes GmbHMedtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC.Vilex Tool — VILEX IN TENNESSEE, INC.Int-Fix — Smith & Nephew, Inc.Cosmolock — Kalitec Direct LLCInvictus — ALPHATEC SPINE, INC.Mariner MIS TLIF Retractor — Seaspine Orthopedics Corporation
Recent 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 |
| 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 |
| 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 driv |
| 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 prem |
| 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 th |
| 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 |
| 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 |
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