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Tap, Bone
FDA product code HWX · Class 1 · Orthopedic
4,925
Registered devices
1,305
Adverse events
15
Recalls
2
510(k) clearances
Devices with this code
General Instrument — ORTHOPEDIATRICS CORP.Telluride MIS Spinal Fixation System — Highridge Medical, LLCMedtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC.Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC.FENESTRATED SCREWS — Orthofix US LLCDIPLOMAT — SIGNUS Medizintechnik GmbHCHARLOTTE — WRIGHT MEDICAL TECHNOLOGY, INC.Mariner Deformity — Seaspine Orthopedics CorporationTapered Tap - 5.5 mm — INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITEDNA — Synthes GmbHNA — DEPUY SPINE, LLCNA — Synthes GmbHMariner Deformity — Seaspine Orthopedics CorporationANAX™ OCT Spinal System — CG MedTech Co.,Ltd.Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC.TAP, CANCELLOUS, CANNULATED, S-COUPLE — Biomet Orthopedics, LLC3.5mm Screw Fastener Tap 145mm — Osteocentric Technologies, Inc.Polaris 5.5 Spinal Fixation System — Highridge Medical, LLCN/A — MEDTRONIC SOFAMOR DANEK, INC.Quantum® Spinal Fixation System — Pioneer Surgical Technology, Inc.RIVA Posterior Fixation System — XENIX MEDICAL LLCInion FreedomScrew instruments — Inion OyNA — DEPUY SPINE, LLCPerfix™ Spinal System — CG MedTech Co.,Ltd.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-02-25 | Synthes (USA) Products LLC | A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incor |
| 2026-02-25 | Synthes (USA) Products LLC | A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incor |
| 2019-04-08 | Zimmer GmbH | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. |
| 2013-05-03 | Surgical Instrument Service And Savings, Inc. | The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch. |
| 2012-04-13 | Smith & Nephew Inc | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. |
| 2010-10-15 | Orthohelix Surgical Designs Inc | The print for modified CSS depth gauges has inaccurate definition of the etched screw length. The error results in a length reading that is longer (5 mm in the |
| 2010-10-15 | Orthohelix Surgical Designs Inc | The print for modified CSS depth gauges has inaccurate definition of the etched screw length. The error results in a length reading that is longer (5 mm in the |
| 2010-10-15 | Orthohelix Surgical Designs Inc | The print for modified CSS depth gauges has inaccurate definition of the etched screw length. The error results in a length reading that is longer (5 mm in the |
| 2010-04-21 | Blackstone Medical, Inc. | Certain lots of the non-cannulated Modular Bone Taps used with the Firebird Spinal Fixation Systems may contain a manufacturing non conformance resulting in the |
| 2010-04-21 | Blackstone Medical, Inc. | Certain lots of the non-cannulated Modular Bone Taps used with the Firebird Spinal Fixation Systems may contain a manufacturing non conformance resulting in the |
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