Home › Device types › HWJ
Awl
FDA product code HWJ · Class 1 · Orthopedic
1,653
Registered devices
322
Adverse events
26
Recalls
4
510(k) clearances
Devices with this code
Alta ACDF System — Highridge Medical, LLCInvictus — ALPHATEC SPINE, INC.Solitaire Cervical Spacer System — Highridge Medical, LLCGeneral Instrument — ORTHOPEDIATRICS CORP.Trigen — Smith & Nephew, Inc.Silicone PIP — Stryker GmbHendophix — Suzhou Endophix Co., Ltd.Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC.Inertia® MIS Pedicle Screw System — NEXXT SPINE, LLCNatural Nail® — Zimmer, Inc.Millennium — Avalign Technologies, Inc.Meridian — Seaspine Orthopedics CorporationMedtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC.NA — Synthes GmbHPOINTED AWL — Biomet Orthopedics, LLCBOSS Instruments — BOSS INSTRUMENTS, LTD., INC.Medtronic Resuable Instruments — MEDTRONIC SOFAMOR DANEK, INC.Vault C ACDF System — PRECISION SPINE, INC.ASCENT — Orthofix US LLCIdentiTi — ALPHATEC SPINE, INC.Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC.HNM MEDICAL — HNM STAINLESS, LLC.Alta ACDF System — Highridge Medical, LLCQuick Connect Awl — Spineup, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-06-04 | SEASPINE ORTHOPEDICS CORPORATION | Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces. |
| 2023-07-07 | Alphatec Spine, Inc. | Awl instrument adjustable drill button assembly assembled in the incorrect orientation, preventing locking feature from engaging with shaft at the desired set p |
| 2020-04-13 | K2M, Inc | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off d |
| 2020-04-13 | K2M, Inc | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off d |
| 2020-04-13 | K2M, Inc | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off d |
| 2020-04-13 | K2M, Inc | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off d |
| 2020-04-13 | K2M, Inc | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off d |
| 2020-04-13 | K2M, Inc | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off d |
| 2020-04-13 | K2M, Inc | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off d |
| 2020-04-13 | K2M, Inc | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off d |
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