Zimmer, Inc.

FDA Regulatory Profile

Summary

Total Recalls
538 (2 Class I)
510(k) Clearances
417
Inspections
11
Compliance Actions
0

Known Names

zimmer, zimmer biomet spine, zimmer spine, zimmer trabecular metal technology

Recent Recalls

NumberClassProductDate
Z-0967-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails MDecember 2, 2025
Z-0976-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails MDecember 2, 2025
Z-0971-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails MDecember 2, 2025
Z-0970-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails MDecember 2, 2025
Z-0974-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails MDecember 2, 2025
Z-0981-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails MDecember 2, 2025
Z-0969-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails MDecember 2, 2025
Z-0972-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails MDecember 2, 2025
Z-0977-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails MDecember 2, 2025
Z-0973-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails MDecember 2, 2025
Z-0979-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails MDecember 2, 2025
Z-0975-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails MDecember 2, 2025
Z-0982-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails MDecember 2, 2025
Z-0968-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails MDecember 2, 2025
Z-0980-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails MDecember 2, 2025
Z-0978-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails MDecember 2, 2025
Z-0983-2026Class IIBrand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails MDecember 2, 2025
Z-0419-2026Class IIZimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 46 mm O.D., Size September 26, 2025
Z-0418-2026Class IIZimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size September 26, 2025
Z-1645-2025Class IIZimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Number 802602202; ProsthesMarch 24, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K253566Affixus Retrograde Femoral Nailing SystemMarch 12, 2026
K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)March 9, 2026
K252623G7® Revision Acetabular SystemFebruary 4, 2026
K251098Identity Revision Humeral StemsAugust 11, 2025
K251906Z1 Hip SystemJuly 18, 2025
K250848Identity Shoulder SystemJuly 2, 2025
K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)March 6, 2025
K243907Affixus Tibial Nailing System - 4mm screwsFebruary 12, 2025
K241873OsseoFit Stemless Shoulder SystemDecember 11, 2024
K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)November 22, 2024
K243247Persona the Personalized Knee SystemOctober 29, 2024
K241651Affixus Tibial and Antegrade Femoral Nailing SystemSeptember 26, 2024
K240876Identity Shoulder SystemJune 12, 2024
K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)April 26, 2024
K230321Persona™ Personalized Knee SystemMarch 8, 2023
K211047CoCr HeadJanuary 10, 2023
K221479Persona Personalized Knee SystemNovember 17, 2022
K222566Zimmer Persona Personalized Knee SystemOctober 17, 2022
K213856Identity Shoulder SystemSeptember 15, 2022
K212512G7® Vivacit-E® Freedom® Constrained LinerApril 28, 2022