Plate, Fixation, Bone
Orthopedic · 21 CFR 888.3030
Recent MDR events
38,818 adverse event reports on file
- QUICKFIX SCREW, 2 X 12 MMJul 31, 2026MalfunctionArthrex, Inc.1220246-2026-04149
- D-M 1.6MM BEADED CABLE SET SSJul 31, 2026InjuryStryker Orthopaedics-mahwah0002249697-2026-00660
- 2.7MM TI MATRIXRIB LCKNG SCREW SELF-DRILLING/10MMJul 31, 2026MalfunctionSynthes Gmbh8030965-2026-07879
- 2.7MM TI MATRIXRIB LCKNG SCREW SELF-DRILLING/10MMJul 31, 2026MalfunctionSynthes Gmbh8030965-2026-07880
- IMPL DELIVERY SYS,DISTAL BICEPS REPRJul 30, 2026MalfunctionArthrex, Inc.1220246-2026-04104
- FIB ANATOMIC LOCK LEFT 4H STEJul 30, 2026InjuryZimmer Biomet, Inc.0001825034-2026-02215
- LCPJul 30, 2026InjurySynthes Gmbh8030965-2026-07845
- AxSOS 3 Proximal Lateral Humerus Plate For Right Humerus 4 Hole / L99mmJul 30, 2026InjuryStryker Gmbh0008031020-2026-00924
- Gorilla Plating System MTP, 0 degree, Medium Plate, LeftJul 30, 2026InjuryParagon 283008650117-2026-00446
- ANTHEMJul 30, 2026MalfunctionGlobus Medical, Inc.3004142400-2026-00154
Event type breakdown
Recalls
286 recall events for this product code
- Acumed LLCOpen, ClassifiedJun 23, 2026
Acumed Hexalob Screw various sizes:
Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.
Z-2532-2026 · View FDA record ↗ - I.T.S. GmbHOpen, ClassifiedMar 20, 2026
Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Z-1592-2026 · View FDA record ↗ - I.T.S. GmbHOpen, ClassifiedMar 20, 2026
Claviculaplate with Angular Stability, with the below descriptions and associated article numbers.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Z-1593-2026 · View FDA record ↗ - I.T.S. GmbHOpen, ClassifiedMar 20, 2026
Brand Name: Humeral Head Plate with Angular Stability, with the following description: Proximal Humeral Plate. Article Numbers: 211341-10, 211341-4, 211341-7, 2
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Z-1594-2026 · View FDA record ↗ - I.T.S. GmbHOpen, ClassifiedMar 20, 2026
FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Z-1595-2026 · View FDA record ↗ - I.T.S. GmbHOpen, ClassifiedMar 20, 2026
Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Z-1596-2026 · View FDA record ↗ - I.T.S. GmbHOpen, ClassifiedMar 20, 2026
Olecranonplate with Angular Stability with the below descriptions and corresponding article numbers.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Z-1597-2026 · View FDA record ↗ - I.T.S. GmbHOpen, ClassifiedMar 20, 2026
I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Z-1598-2026 · View FDA record ↗ - I.T.S. GmbHOpen, ClassifiedMar 20, 2026
Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Z-1600-2026 · View FDA record ↗ - I.T.S. GmbHOpen, ClassifiedMar 20, 2026
I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Z-1601-2026 · View FDA record ↗
Registered firms
4,929 firms currently registered for this product code
Gpc Medical Limited
Ghaziabad Uttar Pradesh, IN
Arthrex, Inc.
Naples, FL, US
Acumed Llc
Hillsboro, OR, US
Avalign Delivery Systems Division
Greenwood, IN, US
Marle Finishing Sas
La Talaudiere Loire, FR
Ptumedical Gmbh
Spaichingen Baden-Wurttemberg, DE
Kls-martin L.p.
Jacksonville, FL, US
Sterigenics Us Llc
Fort Worth, TX, US
Synthes (usa) Products Llc
West Chester, PA, US
Arch Medical Solutions - Warsaw
Warsaw, IN, US
Trimed, Inc.
Santa Clarita, CA, US
Biedermann Motech Gmbh & Co. Kg
VS-SCHWENNINGEN Baden-Wurttemberg, DE
Zimmer Biomet Korea Ltd.
Seoul, KR
Frueh Verpackungstechnik Ag
Fehraltorf Zurich, CH
Hn And M Gmbh
Derendingen Solothurn, CH
Arthrex Australia Pty Ltd.
Frenchs Forest New South Wales, AU
Changzhou Biomet Medical Devices Co., Ltd.
Changzhou City Jiangsu, CN
Paragon Medical Device (changzhou) Co., Ltd.
Changzhou Jiangsu, CN
Arthrex Logistic Center
Fort Myers, FL, US
Jeil Medical Corporation
Siheung-si Gyeonggi, KR
Steris Schweiz Ag
Daniken Solothurn, CH
Synthes Gmbh
Zuchwil Solothurn, CH
Jabil Switzerland Manufacturing Gmbh (raron)
Raron Valais, CH
510(k) clearances
1,320 clearances for this product code
- Newclip TechnicsJul 28, 2026
K261511 · Xpert Ankle
- GM Dos Reis Industria e Comercio Ltda.Jul 21, 2026
K261406 · Versalock Proximal Tibial Plating System
- TriMed, Inc.Jul 16, 2026
K262032 · TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )
- Newclip TechnicsJul 8, 2026
K261191 · Alians Elbow S
- Stryker Leibinger GmbH & Co KGJul 1, 2026
K261054 · RibPlate System
- Bonebridge AGJun 26, 2026
K261351 · SALGINA 2.5mm Distal Radius System
- I.T.S. GmbHJun 16, 2026
K260958 · I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (L
- Tyber Medical, LLCJun 12, 2026
K261207 · Exalta Proximal Tibia Plating System