Orthopedic Manual Surgical Instrument
Orthopedic · 21 CFR 888.4540
Recent MDR events
81,214 adverse event reports on file
- TIBIAL IMPACTOR BLOCKJul 31, 2026MalfunctionZimmer Biomet, Inc.0001822565-2026-02721
- VANGUARD PREMIER 70MM BLOCKJul 31, 2026MalfunctionZimmer Biomet, Inc.0001825034-2026-02226
- METRX IIJul 31, 2026MalfunctionMedtronic Sofamor Danek Usa, Inc.3003120897-2026-01317
- DELTA XTENDJul 31, 2026MalfunctionDepuy Ireland - 96166711818910-2026-13084
- DELTA XTENDJul 31, 2026MalfunctionDepuy Ireland - 96166711818910-2026-13083
- SUTURELASSO, 25 DEGREE TIGHT CURVE RIGHTJul 31, 2026MalfunctionArthrex, Inc.1220246-2026-04138
- GLOBAL APJul 31, 2026MalfunctionDepuy Orthopaedics Inc Us1818910-2026-13088
- MBT REV TIBIAL VIEW PLT SZ5Jul 31, 2026MalfunctionDepuy Orthopaedics Inc Us1818910-2026-13090
- Insertion Guide, Extended Humeral NailJul 31, 2026MalfunctionArthrex, Inc.1220246-2026-04148
- EVEREST MI Tapered Thread Tap, Cannulated Size Ø5.5 mmJul 31, 2026MalfunctionK2m, Inc.3004774118-2026-00216
Event type breakdown
Recalls
526 recall events for this product code
- United Orthopedic Corp.Open, ClassifiedAug 6, 2026
Brand Name: U2 Total Knee System
Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
Z-2898-2026 · View FDA record ↗ - United Orthopedic Corp.Open, ClassifiedAug 5, 2026
Brand Name: U2 Total Knee System
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Z-2885-2026 · View FDA record ↗ - United Orthopedic Corp.Open, ClassifiedAug 5, 2026
Brand Name: U2 Total Knee System
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Z-2886-2026 · View FDA record ↗ - Biomet, Inc.Open, ClassifiedAug 3, 2026
Intramedullary Bone Saw Blade Assembly
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
Z-2867-2026 · View FDA record ↗ - Biomet, Inc.Open, ClassifiedAug 3, 2026
Intramedullary Bone Saw Blade Assembly
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
Z-2868-2026 · View FDA record ↗ - Biomet, Inc.Open, ClassifiedAug 3, 2026
Intramedullary Bone Saw Blade Assembly
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
Z-2869-2026 · View FDA record ↗ - Biomet, Inc.Open, ClassifiedAug 3, 2026
Intramedullary Bone Saw Blade Assembly
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
Z-2870-2026 · View FDA record ↗ - Biomet, Inc.Open, ClassifiedAug 3, 2026
Intramedullary Bone Saw Blade Assembly
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
Z-2871-2026 · View FDA record ↗ - Stryker GmbHOpen, ClassifiedApr 17, 2025
Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S;
The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.
Z-1620-2025 · View FDA record ↗ - Stryker GmbHOpen, ClassifiedApr 17, 2025
Guide Wire with Ruler Tube 3x1000 mm DIA; Catalog number/REF: 2351-3100S;
The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.
Z-1621-2025 · View FDA record ↗
Registered firms
1,154 firms currently registered for this product code
Acumed Llc
Hillsboro, OR, US
Max Hauser Suddeutsche Chirurgiemechanik Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
The Orthopaedic Implant Company
Reno, NV, US
Aurora Spine, Inc.
Carlsbad, CA, US
K2m, Inc.
Leesburg, VA, US
Orthotin Llc
Denville, NJ, US
Ultimate Medical Products Ltd.
SHARJAH Ash Shariqah, AE
Spineology Inc.
Saint Paul, MN, US
Selenium Medical S.a.s.
La Rochelle Charente-Maritime, FR
Transmedic Philippines Inc.
Makati City Manila, PH
Rg Medical Usa
Mount Juliet, TN, US
Arthrex Logistic Center
Fort Myers, FL, US
Medi-g Gmbh
Messkirch Baden-Wurttemberg, DE
Arch Medical Solutions - Warsaw
Warsaw, IN, US
Volgo Care International (private) Limited
Sialkot Punjab, PK
Sobytek Instruments Co.
SIALKOT Punjab, PK
Paragon Medical - Dayton
Dayton, OH, US
Fusionx Medtech Inc.
Whittier, CA, US
Jmg Machine, Inc.
La Mirada, CA, US
Honer Medizin-technik Gmbh & Co. Kg
SPAICHINGEN Baden-Wurttemberg, DE
Mid South Precision
Murfreesboro, TN, US
Classic Wire Cut Company, Inc.
Valencia, CA, US
Synthes Gmbh
Selzach Solothurn, CH
Zimmer Surgical, Inc.
Dover, OH, US
Nutech Spine, Inc.
Birmingham, AL, US
510(k) clearances
58 clearances for this product code
- Sonex Health, Inc.Dec 20, 2019
K192873 · SX-One MicroKnife
- Orthovita, Inc.Apr 1, 2014
K140414 · IMBIBE NEEDLE
- Koros USA, Inc.Dec 9, 2010
K101609 · SELF RETAINING SOFT TISSUE RETRACTOR
- Smith & Nephew, Inc.Jun 14, 2000
K001507 · MICROPERFORATION INSTRUMENT
- Orthopedic Systems, Inc.Jan 22, 1996
K952495 · ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM
- Orthomet, Inc.Apr 26, 1995
K943873 · ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY
- Leibinger L.P.Apr 13, 1995
K944188 · SPINAL MARKER
- Depuy, Inc.Nov 7, 1994
K941896 · STEADMAN LIGAMENT GRAFT PASSER AND PROTECTOR