Appliance, Fixation, Nail/blade/plate Combination, Single Component
Orthopedic · 21 CFR 888.3030
Recent MDR events
910 adverse event reports on file
- 2.0MM DRILL BIT WITH DEPTH MARK/QC/140MMJun 26, 2026MalfunctionSynthes Gmbh8030965-2026-06661
- 2.0MM DRILL BIT WITH DEPTH MARK/QC/140MMJun 16, 2026MalfunctionSynthes Gmbh8030965-2026-06246
- 2.0MM DRILL BIT WITH DEPTH MARK/QC/140MMJun 10, 2026MalfunctionSynthes Gmbh8030965-2026-05757
- ONE-THIRD TUBULAR PLT 10 HOLEMar 25, 2026InjuryZimmer Biomet, Inc.0001822565-2026-00953
- ONE-THIRD TUBULAR PLT 4 HOLEMar 25, 2026InjuryZimmer Biomet, Inc.0001822565-2026-00954
- 2.0MM DRILL BIT WITH DEPTH MARK/QC/140MMMar 13, 2026MalfunctionSynthes Gmbh8030965-2026-02504
- 2.0MM DRILL BIT WITH DEPTH MARK/QC/140MMMar 10, 2026MalfunctionSynthes Gmbh8030965-2026-02375
- 2.0MM DRILL BIT WITH DEPTH MARK/QC/140MMMar 9, 2026MalfunctionSynthes Gmbh8030965-2026-02329
- DRILL BIT Ø2 W/DOUBLE MARKING L140/115 3Jan 16, 2026MalfunctionSynthes Gmbh8030965-2026-00605
- DRILL BIT Ø2 W/DOUBLE MARKING L140/115 3Jan 9, 2026MalfunctionSynthes Gmbh8030965-2026-00321
Event type breakdown
Recalls
57 recall events for this product code
- Synthes USA (HQ), Inc.TerminatedFeb 16, 2011
02.122.550, 50mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System
Potential for out of specification star grind teeth.
Z-1261-2011 · View FDA record ↗ - Synthes USA (HQ), Inc.TerminatedFeb 16, 2011
02.122.550S, 50mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System
Potential for out of specification star grind teeth.
Z-1262-2011 · View FDA record ↗ - Synthes USA (HQ), Inc.TerminatedFeb 16, 2011
02.122.551, 50mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System
Potential for out of specification star grind teeth.
Z-1263-2011 · View FDA record ↗ - Synthes USA (HQ), Inc.TerminatedFeb 16, 2011
02.122.551S, 50mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System
Potential for out of specification star grind teeth.
Z-1264-2011 · View FDA record ↗ - Synthes USA (HQ), Inc.TerminatedFeb 16, 2011
02.122.555, 55mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System
Potential for out of specification star grind teeth.
Z-1265-2011 · View FDA record ↗ - Synthes USA (HQ), Inc.TerminatedFeb 16, 2011
02.122.556, 55mm Spiral Blade, 14mm,
Potential for out of specification star grind teeth.
Z-1267-2011 · View FDA record ↗ - Synthes USA (HQ), Inc.TerminatedFeb 16, 2011
02.122.556S, 55mm Spiral Blade, 14mm,
Potential for out of specification star grind teeth.
Z-1268-2011 · View FDA record ↗ - Synthes USA (HQ), Inc.TerminatedFeb 16, 2011
02.122.561, 60mm Spiral Blade, 14mm,
Potential for out of specification star grind teeth.
Z-1269-2011 · View FDA record ↗ - Synthes USA (HQ), Inc.TerminatedFeb 16, 2011
02.122.561S, 60mm Spiral Blade, 14mm,
Potential for out of specification star grind teeth.
Z-1270-2011 · View FDA record ↗ - Synthes USA (HQ), Inc.TerminatedFeb 16, 2011
02.122.565, 65mm Spiral Blade, 14mm,
Potential for out of specification star grind teeth.
Z-1271-2011 · View FDA record ↗
Registered firms
130 firms currently registered for this product code
Synthes (usa) Products Llc
West Chester, PA, US
Biomet, Inc.
WARSAW, IN, US
Kammerer Medical Systems Gmbh & Co. Kg
Stockach Baden-Wurttemberg, DE
Jabil Inc. (brandywine)
W Chester, PA, US
Sterigenics Us Llc
Los Angeles, CA, US
General Machine, Inc.
Colorado Springs, CO, US
Zimmer Biomet Taiwan Co., Ltd.
Taipei, TW
Stryker Sustainability Solutions
Tempe, AZ, US
Zimmer (shanghai) Medical International Trading Co., Ltd.
Shanghai, CN
Stryker Sustainability Solutions Phoenix
Phoenix, AZ, US
Sterigenics Us, Llc
Lewis Center, OH, US
Arthrex, Inc.
Naples, FL, US
Tornier Inc.
Columbia City, IN, US
Engineered Medical Systems, Llc
Bartlett, TN, US
Kaul Medizintechnik Gmbh
Dierdorf Rhineland-Palatinate, DE
Auxein Medical Private Limited
Sonipat Haryana, IN
Orthofix Srl
BUSSOLENGO Verona, IT
Synthes Gmbh
Zuchwil Solothurn, CH
510(k) clearances
38 clearances for this product code
- Paonan Biotech Co., Ltd.Jun 20, 2019
K182285 · PK High Tibial Osteotomy Correction System
- Advanced Orthopaedic Solutions, Inc. (Aos)Jun 22, 2017
K171606 · AOS Anterolateral Proximal Humeral Plate
- Paragon 28, Inc.Jun 19, 2017
K170693 · Phantom Small Bone Intramedullary Nail System
- Advanced Orthopaedic Solutions, Inc.Mar 15, 2016
K160409 · AOS Anterolateral Proximal Humeral Plate
- Orthofix SrlSep 20, 2012
K122541 · ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP)
- Advanced Orthopaedic Solutions, Inc.May 6, 2008
K080590 · AOS PROXIMAL HUMERAL PLATE
- Synthes (Usa)Mar 20, 2008
K080109 · SYNTHES (USA) MODULAR BLADE PLATE SYSTEM
- Orthofix SrlNov 13, 2006
K062920 · ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP