39 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Repair
FDA Enforcement
Class II
·Ongoing·Biomet, Inc.·October 29, 2025
Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080
FDA Enforcement
Class II
·Ongoing·Biomet, Inc.·October 1, 2025
JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357
FDA Enforcement
Class II
·Ongoing·Biomet, Inc.·November 27, 2024
RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthroplasty Item Number: 11-165206
FDA Enforcement
Class II
·Ongoing·Biomet, Inc.·July 3, 2024
OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee Item Number: CP260602
FDA Enforcement
Class II
·Ongoing·Biomet, Inc.·February 8, 2023
(1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee joint replacement prostheses. Item Number: 183104 (2) Vanguard Knee System PS Open Box Femoral; Right; 62.5 mm Item Number: 183106 (3) Vanguard Knee System PS Open Box Femoral; Right; 65 mm Item Number: 183108 (4) Vanguard Knee System PS Open Box Femoral; Right; 67.5 mm Item Number: 183110 (5) Vanguard Knee System PS Open Box Femoral; Right; 70 mm Item Number: 183112
FDA Enforcement
Class II
·Ongoing·Biomet, Inc.·February 8, 2023
Compress Device Short Anchor Plug, 23 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178565
FDA Enforcement
Class II
·Ongoing·Biomet, Inc.·November 29, 2023
G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number 110024462
FDA Enforcement
Class II
·Ongoing·Biomet, Inc.·March 29, 2023
(1) Vanguard Knee System PS Open Box Femoral; Left; 57.5 mm. Intended for Knee joint replacement prostheses. Item Number: 183122 EXPANDED RECALL: (2) Vanguard Knee System PS Open Box Femoral; Left; 60 mm. Item Number: 183124 (3) Vanguard Knee System PS Open Box Femoral; Left; 62.5 mm. Item Number: 183126
FDA Enforcement
Class II
·Ongoing·Biomet, Inc.·February 8, 2023
Compress Device Segmental Anchor Plug, 16 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178406
FDA Enforcement
Class II
·Ongoing·Biomet, Inc.·November 29, 2023
Compress Device Short Anchor Plug, 26 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178568
FDA Enforcement
Class II
·Ongoing·Biomet, Inc.·November 29, 2023
Compress Device Segmental Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178410
FDA Enforcement
Class II
·Ongoing·Biomet, Inc.·November 29, 2023
Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foil pouch with protective packaging in the form of a polyurethane bag, and sealed closed (inner barrier). The inner barrier is then placed into a PETG tray and sealed with Tyvek lid stock (outer barrier). The sealed double barrier system is placed into a paperboard carton with an IFU and label/indicator dots applied to the carton.
FDA Enforcement
Class II
·Ongoing·Biomet, Inc.·May 1, 2024
Compress Device Short Anchor Plug, 12 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178554
FDA Enforcement
Class II
·Ongoing·Biomet, Inc.·November 29, 2023
Compress Device Short Anchor Plug, 16 MM- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement Item Number: 178558
FDA Enforcement
Class II
·Ongoing·Biomet, Inc.·November 29, 2023
Compress Device Segmental Anchor Plug, 12 MM -For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178402
FDA Enforcement
Class II
·Ongoing·Biomet, Inc.·November 29, 2023
Compress Device Short Anchor Plug, 10 MM-Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement Item Number: 178552
FDA Enforcement
Class II
·Ongoing·Biomet, Inc.·November 29, 2023
Compress Device Segmental Anchor Plug, 18 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178408
FDA Enforcement
Class II
·Ongoing·Biomet, Inc.·November 29, 2023
Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01
FDA Enforcement
Class II
·Ongoing·Biomet, Inc.·December 27, 2023
Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint when used in conjunction with a femoral and tibial component Item Number: 154341
FDA Enforcement
Class II
·Ongoing·Biomet, Inc.·February 1, 2023