Zimmer, Inc.
Zimmer, Inc. holds FDA 510(k) medical device clearances, first cleared 1976, most recent 2026, with 446 FDA device recalls on record.
Top product codes for Zimmer, Inc.
FDA recalls by Zimmer, Inc.
10 most recent of 446- Z-2528-2026 — Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241
- Z-2531-2026 — Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476
- Z-2530-2026 — Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444
- Z-2527-2026 — Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240
- Z-2529-2026 — Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242
- Z-2578-2026 — Brand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment Model/Catalog Number: 42-5572-066-10 Software Version: N/A Product Description: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment Size 9, 9+ 10mm Thicknes Component: N/A
- Z-1946-2026 — Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number: 00-5049-011-00 Software Version: N/A Product Description: Mixing Bowl and Spatula Component: N/A
- Z-0970-2026 — Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509380 Software Version: N/A Product Description: Affixus 9 mm, Length 380 mm, Right, Trochanteric Nail Component: N/A
- Z-0975-2026 — Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609320 Software Version: N/A Product Description: Affixus 9 mm, Length 320 mm, Left, Trochanteric Nail Component: N/A
- Z-0974-2026 — Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609300 Software Version: N/A Product Description: Affixus 9 mm, Length 300 mm, Left, Trochanteric Nail Component: N/A
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 Zimmer, Inc.
1–100 of 376- K260831 — Z1 Hip System
- K261683 — Augment Off-Axis Instrument System
- K251840 — Zimmer® Persona® Personalized Knee System
- K260182 — Avenir® Müller Stem; Avenir Complete Hip System
- K253592 — Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)
- K253566 — Affixus Retrograde Femoral Nailing System
- K253189 — Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)
- K252623 — G7® Revision Acetabular System
- K251098 — Identity Revision Humeral Stems
- K251906 — Z1 Hip System
- K250848 — Identity Shoulder System
- K243724 — Persona® Revision Knee System (Persona Revision SoluTion Femoral Components)
- K243907 — Affixus Tibial Nailing System - 4mm screws
- K241873 — OsseoFit Stemless Shoulder System
- K242543 — Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)
- K243247 — Persona the Personalized Knee System
- K241651 — Affixus Tibial and Antegrade Femoral Nailing System
- K240876 — Identity Shoulder System
- K240299 — Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)
- K230321 — Persona Personalized Knee System
- K221479 — Persona Personalized Knee System
- K222566 — Zimmer Persona Personalized Knee System
- K213856 — Identity Shoulder System
- K212512 — G7® Vivacit-E® Freedom® Constrained Liner
- K210842 — VerSys Cemented Revision/Calcar
- K210829 — Persona Revision Knee System Femoral Metaphyseal Cones
- K210551 — Persona Revision Knee System
- K192798 — Zimmer Segmental System
- K191449 — ZCA All-Poly Acetabular Cups
- K200823 — Zimmer, Inc. Hip Joint Prostheses MR Labeling I
- K200209 — Persona Personalized Knee System
- K191735 — CPT Hip System
- K200151 — Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial Knee Tibial Cut Guide 5 Deg Right Medial Left Lateral, Persona Partial Knee 2MM Tibial Recutter Left Medial Right Lateral, Persona Partial Knee 2MM Tibial Recutter Right Medial Left Lateral, Persona Partial Knee Tibial Drill
- K192660 — Zimmer M/L Taper Hip Prosthesis
- K193180 — Alliance Augmented Glenoid
- K193223 — Persona Personalized Knee System
- K192189 — Avenir Complete Hip System, Size 0 Coxa Vara
- K190656 — Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings
- K190660 — G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System Vivacit-E Vitamin E Highly Crosslinked Polyethylene
- K183457 — Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head
- K191814 — Alliance Glenoid
- K191625 — Persona Revision Knee System
- K191238 — Zimmer Guide Wire Devices
- K190068 — Vanguard XP Knee System
- K182678 — Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling
- K183583 — Vanguard Complete Knee System
- K181171 — Zimmer Biomet Ceramic Heads
- K183136 — Zimmer Segmental System Proximal Femoral Component
- K181307 — Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow
- K181761 — Zimmer Biomet Select Ceramic Heads
- K182048 — Avenir Complete Hip System
- K181947 — Persona Revision Knee System
- K172524 — Zimmer Persona Personalized Knee System
- K173057 — Zimmer Knee Joint Replacement Prostheses MR Labeling
- K173417 — Zimmer Persona Personalized Knee System
- K172767 — Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid
- K172114 — Zimmer Natural Nail System
- K161830 — Zimmer M/L Taper Hip Prosthesis
- K151716 — Cable-Ready Cable Grip System: Cable-Ready Bone Plate System
- K151848 — Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System
- K151907 — Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage Cables
- K152755 — FastFrame External Fixation System-Ankle Spanning
- K152484 — FastFrame External Fixation System - Distal Radius
- K152494 — Zimmer NexGen Complete Knee Solution Tibial and Femoral Augments
- K152841 — Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical Screws
- K151992 — FastFrame External Fixation System - Knee Spanning, FastFrame External Fixation System - Damage Control
- K151448 — Continuum and Trilogy Integrated Taper (IT) Acetabular Systems
- K150889 — Suture Wires and Wire Loops
- K143321 — ITST Intertrochanteric/Subtrochanteric Fixation System
- K150090 — Zimmer Persona Personalized Knee System
- K150626 — Rush Medullary Pins
- K150818 — Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral Fixation System
- K150501 — Zimmer Nexel Total Elbow Ulnar Cement Diverter
- K143165 — Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated Bone Screw System, Herbert Mini Bone Screw
- K143331 — Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS
- K150121 — Zimmer Periarticular Plating System
- K143618 — Kirschner Wires, Steinmann Pins
- K150028 — Zimmer Segmental System XT Components
- K142787 — Zimmer Persona Personalized Knee System
- K143066 — Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile ZPS / Screws and Washers
- K142836 — Zimmer Plates and Screws (ZPS), Forte Screws
- K142281 — ZIMMER M/DN INTRAMEDULLARY FIXATION SYSTEM
- K142579 — Zimmer Periarticular Plating System
- K142442 — MAGNA-FX AND MINI MAGNA-FX CANNULATED SCREW FIXATION SYSTEM
- K141697 — XTRAFIX EXTERNAL FIXATION SYSTEM, XTRAFIX SMALL EXTERNAL FIXATION SYSTEM
- K141840 — TRABECULAR METAL TIBIAL CONE BROACH, TRABECULAR METAL COUPLED TIBIAL CONE BROACH
- K142166 — TOTAL SHIELD SURGICAL +3 more
- K140508 — ZIMMER PLATES AND SCREWS SYSTEM(ZPS)- NON-STERILE PLATES AND SCREWS
- K141517 — ZIMMER PLATES AND SCREWS (ZPS)-NON-STERILE PLATES
- K141734 — ZIMMER PERIARTICULAR LOCKING SYSTEM
- K133378 — ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM
- K133737 — ZIMMER(R) PERSONA THE PERSONALIZED KEE SYSTEM 14X +30MM TAPERED STEM EXTENSION
- K131413 — XTRAFIX SMALL EXTERNAL FIXATION SYSTEM
- K132386 — TOTALSHIELD SURGICAL HELMET SYSTEM
- K133246 — ZIMMER DISTAL RADIUS PLATING SYSTEM
- K130810 — ZIMMER MOTIONLOC SCREW FOR PERIARTICULAR LOCKING PLATE SYSTEM
- K130595 — ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL AND STAINLESS STEEL TIBIAL NAIL
- K123553 — ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM
- K130661 — ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM
- K123862 — ZIMMER NEXEL TOTAL ELBOW
Data sourced from openFDA. This site is unofficial and independent of the FDA.