Home › Device types › HXX
Screwdriver
FDA product code HXX · Class 1 · Orthopedic
8,483
Registered devices
23,256
Adverse events
32
Recalls
4
510(k) clearances
Devices with this code
Shukla Xtract-All Spine MKS1031 (Legacy) — Shukla MedicalORTHOFIX — ORTHOFIX SRLIdentiTi — ALPHATEC SPINE, INC.Tecomet — TECOMET INC.Tecomet — TECOMET INC.NA — Synthes GmbHN/A — MEDTRONIC SOFAMOR DANEK, INC.Equinoxe — Exactech, Inc.Tether — Seaspine Orthopedics CorporationShukla Maxi S9MAXI — Shukla MedicalPolaris 5.5 Spinal Fixation System — Highridge Medical, LLCPRECICE® Intramedullary Limb Lengthening System Instrument — NUVASIVE SPECIALIZED ORTHOPEDICS, INC.Tecomet — TECOMET INC.CosmoLock Pedicle Screw System — Kalitec Direct LLCAmbler Surgical — AMBLER SURGICAL CORP.CHS — Smith & Nephew, Inc.Summa Orthopaedics System Surgical Instrument — Jeil Medical CorporationORTHOFIX — ORTHOFIX SRLTecomet — TECOMET INC.PRO-TOE — WRIGHT MEDICAL TECHNOLOGY, INC.CRANIOPLATE — Aesculap AGTecomet — TECOMET INC.N/A — MEDTRONIC SOFAMOR DANEK, INC.NA — Synthes GmbH
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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