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Tap, Bone
FDA product code HWX · Class 1 · Orthopedic
5,038
Registered devices
1,322
Adverse events
15
Recalls
2
510(k) clearances
Devices with this code
Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC.Maxima™ ACP System — CG MedTech Co.,Ltd.NA — Synthes GmbHN/A — MEDTRONIC SOFAMOR DANEK, INC.RIVA Pedicle Screw System — XENIX MEDICAL LLCMedtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC.LineSider — Highridge Medical, LLCNeo Medical Pedicle Screw System — Neo Medical SANA — DEPUY SPINE, LLCNA — Synthes GmbH13mm HALF TAP CANNULATED — Osteocentric Technologies, Inc.LANCER™/THUNDERBOLT™ Pedicle Screw System — Choice Spine, LPResponse 5.5/6.0 Spine System — ORTHOPEDIATRICS CORP.Navigation Instruments — Seaspine Orthopedics CorporationInvictus — ALPHATEC SPINE, INC.HOLO — Surgalign Spine Technologies, Inc.NA — DEPUY SPINE, LLCMedtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC.RESPONSE SPINE SYSTEM — ORTHOPEDIATRICS CORP.Mariner — Seaspine Orthopedics CorporationMariner — Seaspine Orthopedics CorporationBlade® Anterior Cervical Plate System — NEXXT SPINE, LLCPANGEA — Stryker GmbHNA — DEPUY SPINE, LLC
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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