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Reamer

FDA product code HTO · Class 1 · Orthopedic

9,702
Registered devices
29,419
Adverse events
83
Recalls
14
510(k) clearances

Devices with this code

Trigen — Smith & Nephew, Inc.Titan Modular Shoulder System 2.5 — Smith & Nephew, Inc.Identity™ — Zimmer, Inc.Apelo® / Apelo® MIS — ATLAS SPINE, INC.Integra® — Ascension Orthopedics, Inc.Intramedullary Reamer — TOTAL JOINT ORTHOPEDICS, INC.AESCULAP — Aesculap AGTrigen — Smith & Nephew, Inc.9.0mm Flexible Reamer — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONTHIN SHAFT IM REAMER — Biomet Orthopedics, LLCN/A — Ortho Development CorporationBullet Nose — Biomet Orthopedics, LLCFlex-Thread Ulna — FLOWER ORTHOPEDICS CORPORATIONAcetabular reamer Ø43 with round tooth — MPS Micro Precision Systems AGViant Medical, LLC — VIANT MEDICALTrigen — Smith & Nephew, Inc.NA — Synthes GmbHIdentity™ — Zimmer, Inc.Humelock II Cemented Shoulder System — FX SOLUTIONSPRECICE® Intramedullary Limb Lengthening System Instrument — NUVASIVE SPECIALIZED ORTHOPEDICS, INC.Trigen — Smith & Nephew, Inc.Trigen — Smith & Nephew, Inc.MP Reconstruction System - Instruments — WALDEMAR LINK GmbH & Co. KGLINK Instruments - Drills, reamers and saw blades — WALDEMAR LINK GmbH & Co. KG

Recent recalls

DateFirmReason
2024-01-24Synthes (USA) Products LLCProducts not sterilized, sterility cannot be confirmed
2022-12-07Zimmer, Inc.Two planers were found to be unusable during sawbones shoulder training.
2020-11-19Synthes (USA) Products LLCRIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommend
2020-11-19Synthes (USA) Products LLCRIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommend
2020-11-19Synthes (USA) Products LLCRIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommend
2020-11-19Synthes (USA) Products LLCRIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommend
2020-11-19Synthes (USA) Products LLCRIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommend
2020-11-19Synthes (USA) Products LLCRIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommend
2020-11-19Synthes (USA) Products LLCRIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommend
2020-11-19Synthes (USA) Products LLCRIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommend

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.