Zimmer Manufacturing B.V.

FDA Regulatory Profile

Summary

Total Recalls
91
510(k) Clearances
0
Inspections
8
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1680-2016Class IIHerbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 45 mm Length 47115504507 Herbert CanMay 4, 2016
Z-1684-2016Class IITrilogy self-tapping bone screw Bone screw 4.5x25 selftap 00625004525 Bone screw 4.5x50 selftap 0May 4, 2016
Z-1674-2016Class IIZimmer Plates and Screws (ZPS) 2.7 mm Cortical Screw SelfTapping, 14 mm Length 47482701401May 4, 2016
Z-1673-2016Class IIZimmer Plates and Screws (ZPS) 3.5 mm Cortical Screw SelfTapping, 10 mm Length 47483501001 3.5 mMay 4, 2016
Z-1678-2016Class IIM/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 45 mm Length 002253045May 4, 2016
Z-1677-2016Class IIZimmer Plates and Screws (ZPS) 4.0 mm Cancellous Screw Fully Threaded, 12 mm Length 47484001200 May 4, 2016
Z-1683-2016Class IIHgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 Hgp ii acetabular cup bone screw selfMay 4, 2016
Z-1676-2016Class IIPeriarticular plating system, cancellous bone screw, partially threaded, hex head, 4.0 mm diameter, May 4, 2016
Z-1675-2016Class IIZimmer universal locking system (ULS) 3.5 mm cortical screw selftapping 18 mm length 47493501801May 4, 2016
Z-1679-2016Class IIMini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully Threaded, 5.0 mm DiMay 4, 2016
Z-1681-2016Class IIITST intertrochanteric/subtrochanteric fixation 4.5 mm diameter cortical screw, 3.5 mm hex head, 5May 4, 2016
Z-1682-2016Class IIVersaFx Femoral Fixation System Hex head compression screw 4.7 mm dia. 2 inch (51 mm) length 471May 4, 2016
Z-1341-2016Class IIPersona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 18mm StMarch 17, 2016
Z-1340-2016Class IIPersona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 14mm StMarch 17, 2016
Z-1111-2016Class IIProduct 13 consists of all product under product code HWC , and same usage: Item no: 47486510002January 11, 2016
Z-1142-2016Class IIProduct 44 consists of all product under product code: HWC and same usage: Item no: 114607099 MAJanuary 11, 2016
Z-1103-2016Class IIProduct 5 consists of all products under product code HWC, and same usage: Item no: 474827010January 11, 2016
Z-1107-2016Class IIProduct 9 consists of all product under HRS, and same usage: Item no: 47494502601 4.5 BROAD SCP PJanuary 11, 2016
Z-1150-2016Class IIProduct 52 consists of product code: HWC and same usage: Item no: 525004530 NEXGEN OSTEOTOMY CORTJanuary 11, 2016
Z-1108-2016Class IIProduct 10consists of all product under product code HWC, and same usage: Item no: 47484502601 4.January 11, 2016