openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 12
Zimmer Plates and Screws (ZPS) 3.5 mm Cortical Screw SelfTapping, 10 mm Length 47483501001 3.5 mm Cortical Screw SelfTapping, 14 mm Length 47483501401 3.5 mm Cortical Screw SelfTapping, 16 mm Length 47483501601 3.5 mm Cortical Screw SelfTapping, 24 mm Length 47483502401 3.5 mm Cortical Screw SelfTapping, 30 mm Length 47483503001 3.5 mm Cortical Screw SelfTapping, 40 mm Length 47483504001 3.5 mm Cortical Screw SelfTapping, 75 mm Length 47483507501
Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
device · product 2 of 12
Zimmer Plates and Screws (ZPS) 2.7 mm Cortical Screw SelfTapping, 14 mm Length 47482701401
A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
Code information
LOT: 63292596
Distribution pattern
Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
device · product 3 of 12
Zimmer universal locking system (ULS) 3.5 mm cortical screw selftapping 18 mm length 47493501801
A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
Code information
LOT: 63297474
Distribution pattern
Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
device · product 4 of 12
Periarticular plating system, cancellous bone screw, partially threaded, hex head, 4.0 mm diameter, 16 mm length 47234702116
A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
Code information
LOT: 63146423
Distribution pattern
Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
device · product 5 of 12
Zimmer Plates and Screws (ZPS) 4.0 mm Cancellous Screw Fully Threaded, 12 mm Length 47484001200 4.0 mm Cancellous Screw Fully Threaded, 14 mm Length 47484001400 4.0 mm Cancellous Screw Fully Threaded, 16 mm Length 47484001600 4.0 mm Cancellous Screw Fully Threaded, 18 mm Length 47484001800 4.0 mm Cancellous Screw Fully Threaded, 20 mm Length 47484002000 4.0 mm Cancellous Scrwe Fully Threaded, 22 mm Length 47484002200 4.0 mm Cancellous Screw Fully Threaded, 26 mm Length 47484002600 4.0 mm Cancellous Screw Fully Threaded, 30 mm Length 47484003001 4.0 mm Cancellous Screw Fully Threaded, 32 mm Length 47484003200 4.0 mm Cancellous Screw Fully Threaded, 36 mm Length 47484003600 4.0 mm Cancellous Screw Fully Threaded, 40 mm Length 47484004000 4.0 mm Cancellous Screw Fully Threaded, 45 mm Length 47484004500 4.0 mm Cancellous Screw Fully Threaded, 50 mm Length 47484005000 4.0 mm Cancellous Screw Fully Threaded, 55 mm Length 47484005500 4.0 mm Cancellous Screw Fully Threaded, 60 mm Length 47484006000 4.5 mm Cortical Screw SelfTapping, 16 mm Length 47484501601 4.5 mm Cortical Screw SelfTapping, 18 mm Length 47484501801 4.5 mm Cortical Screw Self-Tapping, 20 mm Length 47484502001 4.5 mm Cortical Screw Self-Tapping, 22 mm Length 47484502201 4.5 mm Cortical Screw SelfTapping, 24 mm Length 47484502401 4.5 mm Cortical Screw SelfTapping, 26 mm Length 47484502601 4.5 mm Cortical Screw SelfTapping, 28 mm Length 47484502801 4.5 mm Cortical Screw SelfTapping, 34 mm Length 47484503401 4.5 mm Cortical Screw SelfTapping, 38 mm Length 47484503801 4.5 mm Cortical Screw SelfTapping, 40 mm Length 47484504001 4.5 mm Cortical Screw SelfTapping, 42 mm Length 47484504201 4.5 mm Cortical Screw SelfTapping, 54 mm Length 47484505401 4.5 mm Cortical Screw Self-Tapping, 58 mm Length 47484505801 4.5 mm Cortical Screw SelfTapping, 64 mm Length 47484506401 4.5 mm Cortical Screw SelfTapping, 66 mm Length 47484506601 4.5 mm Cortical Screw SelfTapping, 68 mm Length 47484506801 4.5 mm Cortical Screw SelfTapping, 70 mm Length 47484507001 6.5 mm Cancellous Screw Fully Threaded, 45 mm Length 47486504500 6.5 mm Cancellous Screw Fully Threaded, 55 mm Length 47486505500 6.5 mm Cancellous Screw Fully Threaded, 60 mm Length 47486506000 6.5 mm Cancellous Screw, 32 mm Thread Length, 60 mm Length 47486506002 6.5 mm Cancellous Screw Fully Threaded, 65 mm Length 47486506500 6.5 mm Cancellous Screw, 32 mm Thread Length, 65 mm Length 47486506502 6.5 mm Cancellous Screw Fully Threaded, 70 mm Length 47486507000 6.5 mm Cancellous Screw, 16 mm Thread Length, 80 mm Length 47486508001 6.5 mm Cancellous Screw, 32 mm Thread Length, 80 mm Length 47486508002 6.5 mm Cancellous Screw, 32 mm Thread Length, 85 mm Length 47486508502
Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
device · product 6 of 12
M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 45 mm Length 00225304542 M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 70 mm Length 00225307042
A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
Code information
LOTS: 63295051 63293672
Distribution pattern
Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
device · product 7 of 12
Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully Threaded, 5.0 mm Diameter, 20 mm Length 00114205020 Mini Magna-Fx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully Threaded, 5.0 mm Diameter, 36 mm Length 00114205036 Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Partially Threaded, 5.0 mm Diameter, 24 mm Length 00114205124 Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Partially Threaded, 5.0 mm Diameter, 28 mm Length 00114205128 Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Partially Threaded, 5.0 mm Diameter, 30 mm Length 00114205130 Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Partially Threaded, 5.0 mm Diameter, 38 mm Length 00114205138 Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Partially Threaded, 5.0 mm Diameter, 48 mm Length 00114205148 Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Partially Threaded, 5.0 mm Diameter, 65 mm Length 00114205165 MagnaFx Cannulated Screw Fixation System Cannulated Bone Screw, Fully Threaded, 7.0 mm Diameter, 55 mm Length 00114605599 MagnaFx Cannulated Screw Fixation System Cannulated Bone Screw, Fully Threaded, 7.0 mm Diameter, 60 mm Length 00114606099 MagnaFx Cannulated Screw Fixation System Cannulated Bone Screw, 32 mm Thread Length, 7.0 mm Diameter, 65 mm Length 00114606532 MagnaFx Cannulated Screw Fixation System Cannulated Bone Screw, Fully Threaded, 7.0 mm Diameter, 65 mm Length 00114606599 Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully Threaded, 5.0 mm Diameter, 12 mm Length 00114205012
Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
device · product 8 of 12
Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 45 mm Length 47115504507 Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 75 mm Length 47115507507 Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 90 mm Length 47115509007
A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
Code information
LOTS: 63303808 63292589 63292588
Distribution pattern
Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
device · product 9 of 12
ITST intertrochanteric/subtrochanteric fixation 4.5 mm diameter cortical screw, 3.5 mm hex head, 57 mm length 00225305745
A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
Code information
LOT: 63275969
Distribution pattern
Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
device · product 10 of 12
VersaFx Femoral Fixation System Hex head compression screw 4.7 mm dia. 2 inch (51 mm) length 47116202400
A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
Code information
LOT: 63290189
Distribution pattern
Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
device · product 11 of 12
Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 Hgp ii acetabular cup bone screw selftap 6.5x20mm 00662406520 Hgp ii acetabular cup bone screw selftap 6.5x25mm 00662406525 Hgp ii acetabular cup bone screw selftap 6.5x35mm 00662406535 Hgp ii acetabular cup bone screw selftap 6.5x55mm 00662406550 Hgp ii acetabular cup bone screw selftap 6.5x60mm 00662406560
Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
device · product 12 of 12
Trilogy self-tapping bone screw Bone screw 4.5x25 selftap 00625004525 Bone screw 4.5x50 selftap 00625004550 Bone screw 6.5x15 selftap 00625006515 Bone screw 6.5x20 selftap 00625006520 Bone screw 6.5x25 selftap 00625006525 Bone screw 6.5x30 selftap 00625006530
Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.