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Reamer
FDA product code HTO · Class 1 · Orthopedic
9,784
Registered devices
29,528
Adverse events
83
Recalls
14
510(k) clearances
Devices with this code
INTEGRAL 180MM TAPERED/CYLINDRICAL — Biomet Orthopedics, LLCNA — Medos International SàrlCrossRoads — ProvisionTrigen — Smith & Nephew, Inc.Trigen — Smith & Nephew, Inc.ADJUSTABLE REAMER - LONG — Biomet Orthopedics, LLCTrigen — Smith & Nephew, Inc.MotoBAND™ CP DynaForce® MPJ Cup and Cone Reamer Kit, 24mm — CROSSROADS EXTREMITY SYSTEMSLegion Revision — Smith & Nephew, Inc.Viant Medical, LLC — VIANT MEDICALNA — DEPUY ORTHOPAEDICS, INC.IMPIX-L — MEDICREA INTERNATIONALTrigen — Smith & Nephew, Inc.PROSPACE — Aesculap AGTHIN SHAFT IM REAMER — Biomet Orthopedics, LLCIncompass Total Ankle System — WRIGHT MEDICAL TECHNOLOGY, INC.U2™ Hip — UNITED ORTHOPEDIC CORP.INSTRUMENT — Howmedica Osteonics Corp.UniSyn Hip System — Shalby Advanced Technologies, Inc.TRIGEN — Smith & Nephew, Inc.8.0X380MM BULLET-TIP REAMER — Zimmer, Inc.Cup Reamer Size 64 — Incipio Devices SADELTA XTEND — DEPUY (IRELAND)NA — DEPUY ORTHOPAEDICS, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-01-24 | Synthes (USA) Products LLC | Products not sterilized, sterility cannot be confirmed |
| 2022-12-07 | Zimmer, Inc. | Two planers were found to be unusable during sawbones shoulder training. |
| 2020-11-19 | Synthes (USA) Products LLC | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommend |
| 2020-11-19 | Synthes (USA) Products LLC | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommend |
| 2020-11-19 | Synthes (USA) Products LLC | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommend |
| 2020-11-19 | Synthes (USA) Products LLC | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommend |
| 2020-11-19 | Synthes (USA) Products LLC | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommend |
| 2020-11-19 | Synthes (USA) Products LLC | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommend |
| 2020-11-19 | Synthes (USA) Products LLC | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommend |
| 2020-11-19 | Synthes (USA) Products LLC | RIA 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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