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Orthopedic Manual Surgical Instrument
FDA product code LXH · Class 1 · Orthopedic
147,518
Registered devices
82,132
Adverse events
526
Recalls
58
510(k) clearances
Devices with this code
4CIS® INSTRUMENT SYSTEM — ALPHA AI CO.,LTD.NA — Medyssey Co., Ltd.PROMOS — Smith & Nephew, Inc.Knee Instruments — Medacta International SAKnee Instruments — Medacta International SAKnee Instruments — Medacta International SASpine Instruments — Medacta International SACastleLoc Pectus Bar System Instrument Set — L&K BIOMED CO. ,LTD.GPC — GPC MEDICAL LIMITED4CIS® INSTRUMENT SYSTEM — ALPHA AI CO.,LTD.N/A — TDM Co., Ltd.Construct ™ — Ascension Orthopedics, Inc.NA — Medyssey Co., Ltd.MIS FUSION Instruments — Rti Surgical, Inc.Cross-Fuse® II PEEK IBF System — Rti Surgical, Inc.ORIO — SPINECRAFT, LLCTERRA NOVA® MI Access System — VB Spine LLCIlluminator Tip Clamp — KOROS U.S.A., INC.ACUMED — Acumed LLCACUMED — Acumed LLCSureMAX — ADDITIVE IMPLANTS, LLCCASCADIA™ Interbody System — VB Spine LLCApelo® / Apelo® MIS — ATLAS SPINE, INC.NA — Synthes GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-01 | Biomet, Inc. | Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier pac |
| 2026-07-01 | Biomet, Inc. | Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier pac |
| 2026-07-01 | Biomet, Inc. | Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier pac |
| 2026-07-01 | Biomet, Inc. | Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier pac |
| 2026-07-01 | Biomet, Inc. | Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier pac |
| 2026-05-20 | United Orthopedic Corp. | Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail. |
| 2026-05-20 | United Orthopedic Corp. | Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail. |
| 2026-03-19 | United Orthopedic Corp. | Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant. |
| 2025-03-28 | Stryker GmbH | The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery. |
| 2025-03-28 | Stryker GmbH | The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery. |
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