Awl
Orthopedic · 21 CFR 888.4540
Recent MDR events
313 adverse event reports on file
- SCARLETJul 27, 2026InjurySpineart Sa3007728266-2026-00017
- AWL F/TENJul 15, 2026MalfunctionSynthes Gmbh8030965-2026-07155
- ENDOSKELETON¿ TAS INTERBODY SYSTEMJun 30, 2026MalfunctionMedtronic Sofamor Danek Usa, Inc.3003120897-2026-01112
- 14.0MM CANNULATED AWLJun 16, 2026MalfunctionSynthes Gmbh8030965-2026-06243
- DIVERGENCE MINI-PLATE SYSTEMMay 19, 2026MalfunctionMedtronic Sofamor Danek Usa, Inc.3003120897-2026-00909
- ENDOSKELETON¿ TCS INTERBODY SYSTEMMay 8, 2026MalfunctionTitan Spine, A Division Of Medtronic3011577940-2026-00012
- SYNFIX® EVOLUTION AWL/WITHOUT SLEEVEMay 5, 2026MalfunctionSynthes Gmbh8030965-2026-04244
- SYNFIX® EVOLUTION AWL/WITHOUT SLEEVEMay 5, 2026MalfunctionSynthes Gmbh8030965-2026-04245
- ENDOSKELETON¿ TCS INTERBODY SYSTEMApr 16, 2026MalfunctionMedtronic Sofamor Danek Usa, Inc.3003120897-2026-00711
- MACS TL IMPLANTSApr 16, 2026InjuryAesculap Ag3005673311-2026-00068
Event type breakdown
Recalls
26 recall events for this product code
- SEASPINE ORTHOPEDICS CORPORATIONOpen, ClassifiedJul 15, 2024
Brand Name: Meridian Angled Awl Fixed
Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces.
Z-2357-2024 · View FDA record ↗ - Alphatec Spine, Inc.Open, ClassifiedAug 28, 2023
LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral Interbody Systems, IdentiTi LIF, Transcend LIF and Battalion LLIF,
Awl instrument adjustable drill button assembly assembled in the incorrect orientation, preventing locking feature from engaging with shaft at the desired set point; instruments lack ability to control awl depth by means of adjustable shaft advancement stop, which may lead to over insertion, dural tear, vascular/neurologic injury, adjacent tissue damage, increased operative time, revision surgery.
Z-2475-2023 · View FDA record ↗ - K2M, IncTerminatedApr 24, 2020
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90107, UDI # 10888857108202, Size 24x4mm, 6
The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
Z-2008-2020 · View FDA record ↗ - K2M, IncTerminatedApr 24, 2020
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90109, UDI # 10888857108226, Size 24x6mm, 6
The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
Z-2009-2020 · View FDA record ↗ - K2M, IncTerminatedApr 24, 2020
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90111, UDI # 10888857108240, Size 24x8mm, 6
The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
Z-2010-2020 · View FDA record ↗ - K2M, IncTerminatedApr 24, 2020
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90113, UDI # 10888857108264, Size 24x10mm,
The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
Z-2011-2020 · View FDA record ↗ - K2M, IncTerminatedApr 24, 2020
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90115, UDI # 10888857108288, Size 24x12mm,
The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
Z-2012-2020 · View FDA record ↗ - K2M, IncTerminatedApr 24, 2020
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90121, UDI # 10888857108349, Size 24x4mm, 1
The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
Z-2013-2020 · View FDA record ↗ - K2M, IncTerminatedApr 24, 2020
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90123, UDI # 10888857108363, Size 24x6mm, 1
The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
Z-2014-2020 · View FDA record ↗ - K2M, IncTerminatedApr 24, 2020
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90125, UDI # 10888857108387, Size 24x8mm, 1
The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
Z-2015-2020 · View FDA record ↗
Registered firms
325 firms currently registered for this product code
Millstone Medical Outsourcing Llc.
FALL RIVER, MA, US
Osseus Fusion Systems Llc
Dallas, TX, US
Orthopediatrics, Corp
Warsaw, IN, US
Lenox-maclaren Surgical Corp.
LOUISVILLE, CO, US
Depuy Spine, Inc.
RAYNHAM, MA, US
Ultimate Medical Products Ltd.
SHARJAH Ash Shariqah, AE
Win Wings Corp.
SIALKOT Punjab, PK
Green Or Llc
Lakeville, MN, US
Inion Oy
TAMPERE Pirkanmaa, FI
Jabil Switzerland Manufacturing Gmbh (le Locle)
Le Locle Neuchatel, CH
Instru-med Technologies
Warsaw, IN, US
Sterigenics U.s. Llc
Hayward, CA, US
Depuy Synthes Sales
Bridgewater, MA, US
Limacorporate S.p.a.
Villanova di San Daniele Udine, IT
Pioneer Surgical Technology, Inc.
Marquette, MI, US
Solco Biomedical Company India Private Limited
KADI Gujarat, IN
Howmedica Osteonics Corp
MAHWAH, NJ, US
Novo Surgical, Inc.
Westmont, IL, US
Turnco Tool & Instrument, Inc.
Georgetown, TX, US
Gauthier Biomedical, Inc.
Grafton, WI, US
Single Source Medical Llc
Churubusco, IN, US
Kico Knee Innovation Company
Frenchs Forest New South Wales, AU
Norwood Medical Llc
Dayton, OH, US
Ksi Co., Ltd.
Gotemba Shizuoka, JP
Depuy Orthopaedics
BRIDGEWATER, MA, US
510(k) clearances
4 clearances for this product code