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Awl
FDA product code HWJ · Class 1 · Orthopedic
1,613
Registered devices
313
Adverse events
26
Recalls
4
510(k) clearances
Devices with this code
Curved Entry Awl — Orthopedic Designs North America, Inc.4WEB Medical — 4web MedicalOsteoFab Suture Anchor — OXFORD PERFORMANCE MATERIALS, INC.NewPort — Seaspine Orthopedics CorporationMICRONAIL — WRIGHT MEDICAL TECHNOLOGY, INC.TOMCAT Cervical Spinal System — Choice Spine, LPSklar® — SKLAR CORPORATIONN/A — Smith & Nephew, Inc.SWANSON — WRIGHT MEDICAL TECHNOLOGY, INC.T-Handle — BIOPRO, INC.Indy — Altus Spine, LLCComplete Cervical Stand Alone IBD — Seaspine Orthopedics CorporationMedtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC.Endo-Model Knee System - Instruments — WALDEMAR LINK GmbH & Co. KGMedicon — Medicon eG. Chirurgiemechaniker-GenossenschaftIrix-A Lumbar Integrated Fusion System — Xtant Medical Holdings, Inc.Symmetry Surgical — ASPEN SURGICAL PRODUCTS, INC.DANIEL NASAL AWL — SONTEC INSTRUMENTS, INC.AMP-LTX — ALPHATEC SPINE, INC.Indy — Altus Spine, LLCBrickyard Stand-Alone ALIF — Altus Spine, LLCSCARLET AL-T INSTRUMENTATION — SpineArt SAGenie RCR Instruments — OSTEONIC CO.,Ltd.Ambler Surgical — AMBLER SURGICAL CORP.
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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