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Biomet, Inc.

FDA Regulatory Profile

Summary

Total Recalls
274
510(k) Clearances
442
Inspections
10
Compliance Actions
2

Known Names

biomet, biomet 3i, biomet manufacturing, biomet microfixation, biomet spine, biomet spine and bone healing technologies

Recent Recalls

NumberClassProductDate
Z-0212-2026Class IIBIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation SysSeptember 23, 2025
Z-2619-2025Class IIJuggerknot Mini Soft Anchors, Model/Catalog Number: 912080September 9, 2025
Z-0477-2025Class IIJuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357October 21, 2024
Z-2179-2024Class IIRingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthroplasty ItMay 17, 2024
Z-1607-2024Class IIVanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product March 13, 2024
Z-0570-2024Class IIBiolox Ceramic Option Head Zimmer 12/14 40mm +0, Item Number 00-8777-040-02November 2, 2023
Z-0569-2024Class IIBiolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01November 2, 2023
Z-0370-2024Class IICompress Device Segmental Anchor Plug, 10 MM-For Correction of revision of unsuccessful osteotomy, aOctober 9, 2023
Z-0387-2024Class IICompress Device Short Anchor Plug, 26 MM-For Correction of revision of unsuccessful osteotomy, arthrOctober 9, 2023
Z-0374-2024Class IICompress Device Segmental Anchor Plug, 18 MM-For Correction of revision of unsuccessful osteotomy, aOctober 9, 2023
Z-0381-2024Class IICompress Device Short Anchor Plug, 16 MM- Correction of revision of unsuccessful osteotomy, arthrodeOctober 9, 2023
Z-0385-2024Class IICompress Device Short Anchor Plug, 23 MM-For Correction of revision of unsuccessful osteotomy, arthrOctober 9, 2023
Z-0373-2024Class IICompress Device Segmental Anchor Plug, 16 MM-For Correction of revision of unsuccessful osteotomy, aOctober 9, 2023
Z-0379-2024Class IICompress Device Short Anchor Plug, 12 MM-For Correction of revision of unsuccessful osteotomy, arthrOctober 9, 2023
Z-0371-2024Class IICompress Device Segmental Anchor Plug, 12 MM -For Correction of revision of unsuccessful osteotomy, October 9, 2023
Z-0375-2024Class IICompress Device Segmental Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, aOctober 9, 2023
Z-0378-2024Class IICompress Device Short Anchor Plug, 10 MM-Correction of revision of unsuccessful osteotomy, arthrodesOctober 9, 2023
Z-0383-2024Class IICompress Device Short Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, arthrOctober 9, 2023
Z-0376-2024Class IICompress Device Segmental Anchor Plug, 22 MM-For Correction of revision of unsuccessful osteotomy, aOctober 9, 2023
Z-0386-2024Class IICompress Device Short Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrOctober 9, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K241014Biomet Kirschner Wires (K-Wires)May 22, 2024
K222760StageOne™ Select Hip Cement Spacer MoldsDecember 28, 2022
K221968StageOne™ Shoulder Cement Spacer MoldsSeptember 15, 2022
K213287StageOne Knee Cement Spacer MoldsSeptember 2, 2022
K212431Biomet Answer/Impact/Integral Distal Centralizer/Centering SleeveFebruary 7, 2022
K212435Comprehensive Humeral Fracture Positioning SleevesDecember 10, 2021
K210192A.L.P.S. Clavicle Plating SystemFebruary 19, 2021
K193214WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System, Biomet Headless CNovember 10, 2020
K193546Distal CentralizersSeptember 25, 2020
K193373Comprehensive® Reverse ShoulderApril 15, 2020
K193402ALLthread PEEK Suture AnchorMarch 5, 2020
K193451Titanium Interference ScrewsFebruary 24, 2020
K193533WIN Flexible Nail SystemFebruary 20, 2020
K192942ALLthread Titanium Suture AnchorJanuary 16, 2020
K193092TunneLoc Tibial Fixation DeviceJanuary 2, 2020
K191459JuggerStitch Meniscal Repair DeviceSeptember 13, 2019
K190035Biomet Headless Compression and Twist-Off ScrewsFebruary 7, 2019
K183553Compress and Mini Compress Anti-Rotation SpindlesJanuary 22, 2019
K183162Affixus Hip Fracture NailDecember 14, 2018
K173767A. L. P. S. Clavicle Plating SystemApril 6, 2018