Biomet, Inc.
Biomet, Inc. holds FDA 510(k) medical device clearances, first cleared 1978, most recent 2026, with 255 FDA device recalls on record.
Top product codes for Biomet, Inc.
FDA recalls by Biomet, Inc.
10 most recent of 255- Z-2868-2026 — Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475625 Product Description: Intramedullary Bone Saw Blade Assembly 13mm
- Z-2867-2026 — Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product Description: Intramedullary Bone Saw Blade Assembly 12mm
- Z-2870-2026 — Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product Description: Intramedullary Bone Saw Blade Assembly 15mm
- Z-2871-2026 — Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product Description: Intramedullary Bone Saw Blade Assembly 16mm
- Z-2869-2026 — Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product Description: Intramedullary Bone Saw Blade Assembly 14mm
- Z-0212-2026 — BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Repair
- Z-2619-2025 — Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080
- Z-0477-2025 — JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357
- Z-2179-2024 — RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthroplasty Item Number: 11-165206
- Z-1607-2024 — 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.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Biomet, Inc.
1–100 of 442- K253434 — OSSTM Orthopedic Salvage System
- K251270 — Taperloc® Complete Hip Stem
- K241014 — Biomet Kirschner Wires (K-Wires)
- K222760 — StageOne Select Hip Cement Spacer Molds
- K221968 — StageOne Shoulder Cement Spacer Molds
- K213287 — StageOne Knee Cement Spacer Molds
- K212431 — Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve
- K212435 — Comprehensive Humeral Fracture Positioning Sleeves
- K210192 — A.L.P.S. Clavicle Plating System
- K193214 — WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System, Biomet Headless Compression and Twist-Off Screws
- K193546 — Distal Centralizers
- K193373 — Comprehensive® Reverse Shoulder
- K193402 — ALLthread PEEK Suture Anchor
- K193451 — Titanium Interference Screws
- K193533 — WIN Flexible Nail System
- K192942 — ALLthread Titanium Suture Anchor
- K193092 — TunneLoc Tibial Fixation Device
- K191459 — JuggerStitch Meniscal Repair Device
- K190035 — Biomet Headless Compression and Twist-Off Screws
- K183553 — Compress and Mini Compress Anti-Rotation Spindles
- K183162 — Affixus Hip Fracture Nail
- K173767 — A. L. P. S. Clavicle Plating System
- K173826 — THP Hip Fracture Plating System
- K173278 — ToggleLoc System
- K172408 — Biomet Bone Cement R
- K171540 — Refobacin Bone Cement R
- K171054 — Biomet Knee Joint Replacement Prostheses
- K162559 — Move Forward 3D Motion Simulation Service
- K161273 — StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis
- K161592 — Persona Partial Knee System
- K162424 — Ulna Plating System
- K161166 — StageOne Select Cement Spacer Molds for Temporary Hip Replacement
- K160071 — StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis
- K161190 — G7 Dual Mobility System, Active Articulation System
- K153657 — Vanguard XP Knee System
- K160058 — Biomet Variable Pitch Compression Screw System
- K152621 — OSS/Arcos IM Total Femur Rod
- K151603 — Arcos One-piece Femoral Revision System
- K150850 — Refobacin Bone Cement R
- K150867 — Affixus Tibial Nailing System
- K150522 — G7 Dual Mobility System
- K150503 — Echo Bi-Metric Microplasty Line Extension
- K143192 — Vanguard 360 Revision Knee System
- K142882 — G7 Freedom and Offset Liners, Freedom Head, Size 32
- K143543 — Prelude PF Patellae
- K142933 — Biomet Tibial trays
- K143009 — Echo Bi-Metric Microplasty Hip System
- K140669 — G7 OSSEOTI ACETUBLAR SHELLS
- K141331 — BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS)
- K141407 — VANGUARD XP FEMORAL COMPONENT(GEN II)/VANGUARD XP FEMORAL TRIAL
- K142295 — Sirius Femoral Stem, Size 30A
- K141762 — PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEM
- K141653 — BIOLOX DELTA CERAMIC OPTION HEADS
- K140883 — VANGUARD 360 OSSEOTI TIBIAL SLEEVE AUGMENT
- K140902 — E1 SERIES A PATELLAE, STANDARD 3-PEG, E1 SERIES A PATELLAE, THIN 3-PEG, E1 SERIES PATELLAE, ASYMMETRICAL, 3-PEG
- K140891 — BIOMET CANNULATED SCREW SYSTEM
- K140622 — DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE
- K140625 — ORTHOSORB LS
- K140018 — TSP HIP FRACTURE PLATING SYSTEM
- K133354 — PERI-PROSTHETIC CABLE SYSTEM
- K132873 — VANGUARD XP KNEE SYSTEM
- K131867 — 2.5MM INLINE FUSION PLATE
- K131684 — BIOLOX(R) DELTA CERAMIC HEADS
- K130610 — SIRIUS FEMORAL STEM
- K130126 — SIGNATURE PERSONALIZED PATIENT CARE SYSTEM - GLENOID GUIDE SYSTEM
- K131670 — LAPIDUS PLATE, 3.5MM INLINE FUSION PLATE, 3.5MM MTP PLATE (LEFT AND RIGHT)
- K130063 — ARCOS TROCHANTER BUTTON
- K123501 — OSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTS
- K120121 — COMPREHENSIVE REVERSE SHOULDER-MINI BASEPLATE
- K111746 — COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS)
- K110201 — EXPLOR RADIAL HEAD PLATING SYSTEM
- K110145 — BIOMET SPORTS MEDICINE JUGGERKNOT SOFT ANCHOR
- K102125 — PATIENT-SPECIFIC VANGUARD FEMORAL COMPONETS
- K093293 — VANGUARD 360 REVISION KNEE SYSTEM
- K100114 — FAT CONCENTRATION SYSTEM
- K101086 — TAPERLOC COMPLETE
- K093235 — RINGLOC + HYBRID ACETABULAR SYSTEM
- K091722 — COAXIAL APPLICATOR SYSTEM
- K092150 — COBALT MV WITH GENTAMICIN (AKA COBALT G-MV) BONE CEMENT
- K090757 — BIOMET MODULAR FEMORAL REVISION SYSTEM
- K090103 — 100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALL
- K082996 — BIOLOX DELTA OPTION CERAMIC HEADS
- K082446 — BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS
- K080642 — COMPREHENSIVE REVERSE SHOULDER
- K080330 — SEGMENTAL DISTAL FEMORAL COMPONENTS AND PROXIMAL FEMORAL BODIES WITH A COMPRESS FEMALE TAPER
- K080361 — REGENEREX TIBIAL COMPONENTS
- K080204 — VANGUARD KNEE SYSTEM TITANIUM FEMORAL COMPONENTS
- K072330 — CONTROLLED DELIVERY FOR OSTEOPLASTY (CDO SYSTEM) AND GRAFT PREPARATION SYSTEM
- K071569 — ALLTHREAD PEEK ANCHOR WITH TANTALUM MARKER
- K071053 — RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD
- K070364 — 100KGY E-POLY MAXROM ACETABULAR LINERS
- K070369 — REGENERX RINGLOC + MODULAR ACETABULAR SHELLS
- K061312 — 36MM BIOLOX DELTA CERAMIC HEADS
- K052990 — STAGEONE DISPOSABLE CEMENT SPACER MOLD FOR TEMPORARY HIP PROSTHESIS WITH REINFORCEMENT STEM
- K052255 — ARCOMXL POLYETHYLENE RX90 ACETABULAR LINERS
- K052685 — ORTHOPEDIC SALVAGE SYSTEM- OSS
- K050124 — POROUS COATED ACETABULAR COMPONENTS
- K051569 — RINGLOC BI-POLAR ACETABULAR COMPONENT
- K051843 — COPELAND EAS HUMERAL RESURFACING HEADS
- K050327 — E-POLY (VITAMIN E) ACETABULAR LINERS
Data sourced from openFDA. This site is unofficial and independent of the FDA.