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Rongeur
FDA product code HTX · Class 1 · Orthopedic
14,811
Registered devices
615
Adverse events
7
Recalls
5
510(k) clearances
Devices with this code
Kerrison Rongeur — KOROS U.S.A., INC.Medicon — Medicon eG. Chirurgiemechaniker-GenossenschaftSymmetry Kerrison — ASPEN SURGICAL PRODUCTS, INC.PILLING — TELEFLEX INCORPORATEDNovo Surgical — NOVO SURGICAL, INC.PEAK MED — Peak Medical Distribution Inc.gSource — GSOURCE LLCLeksell Duckbill Rongeur — SONTEC INSTRUMENTS, INC.Disc Prep — Seaspine Orthopedics CorporationNovo Surgical — NOVO SURGICAL, INC.RONGEUR — KLS-Martin L.P.Foramenotomy Rongeur — KOROS U.S.A., INC.Medicon — Medicon eG. Chirurgiemechaniker-GenossenschaftgSource — GSOURCE LLCSklar® — SKLAR CORPORATIONPEAK MED — Peak Medical Distribution Inc.AESCULAP — Aesculap AGSurgical Direct — Surgical Direct, Inc.Rongeur — KOROS U.S.A., INC.Ejector Punch Plus Rongeur — KOROS U.S.A., INC.Kerrison Ronguer — KOROS U.S.A., INC.PEAK MED — Peak Medical Distribution Inc.RZ Medizintechnik GmbH — RZ-Medizintechnik GmbHNovo Surgical Inc. — NOVO SURGICAL, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-03 | Sklar Instruments | Reports of various packaging issues that may result in a breach of the sterile barrier. |
| 2017-05-25 | Exactech, Inc. | Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the sur |
| 2017-05-25 | Exactech, Inc. | Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the sur |
| 2017-05-25 | Exactech, Inc. | Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the sur |
| 2017-05-25 | Exactech, Inc. | Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the sur |
| 2017-05-25 | Exactech, Inc. | Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the sur |
| 2017-05-25 | Exactech, Inc. | Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the sur |
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