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Rongeur
FDA product code HTX · Class 1 · Orthopedic
14,952
Registered devices
623
Adverse events
7
Recalls
5
510(k) clearances
Devices with this code
Sklar® — SKLAR CORPORATIONSklar — SKLAR CORPORATIONNovo Surgical Inc. — NOVO SURGICAL, INC.HNM Medical — HNM STAINLESS, LLC.Novo Surgical — NOVO SURGICAL, INC.PEAK MED — Peak Medical Distribution Inc.RZ Medizintechnik GmbH — RZ-Medizintechnik GmbHSurgical Direct — Surgical Direct, Inc.Surgical Direct — Surgical Direct, Inc.Integra® Jarit® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONSklar® — SKLAR CORPORATIONNovo Surgical — NOVO SURGICAL, INC.Wiggins Medical — Ebner Medical, LLCNovo Surgical — NOVO SURGICAL, INC.RZ Medizintechnik GmbH — RZ-Medizintechnik GmbHGeneral Instrument — ALPHATEC SPINE, INC.Illico — ALPHATEC SPINE, INC.WEIL CUT THRU RONGEUR — SONTEC INSTRUMENTS, INC.Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC.AESCULAP — Aesculap AGIntegra® Jarit® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONATEC Instruments — ALPHATEC SPINE, INC.Medicon — Medicon eG. Chirurgiemechaniker-GenossenschaftMedicon — Medicon eG. Chirurgiemechaniker-Genossenschaft
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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