Zimmer Biomet, Inc.

FDA Regulatory Profile

Summary

Total Recalls
875 (3 Class I)
510(k) Clearances
5
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0696-2021Class IISpinal Rod Cutter, Item number 00392500200. The product is a nonsterile pin cutter - Product Usage: November 20, 2020
Z-0570-2021Class IIPolaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacral pedicle screw sysNovember 17, 2020
Z-0340-2021Class IIZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with SSeptember 24, 2020
Z-0348-2021Class IIZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with September 24, 2020
Z-0364-2021Class IIZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face,September 24, 2020
Z-0370-2021Class IIZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face,September 24, 2020
Z-0327-2021Class IIZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with SSeptember 24, 2020
Z-0386-2021Class IIZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face,September 24, 2020
Z-0361-2021Class IIZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face,September 24, 2020
Z-0356-2021Class IIZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with September 24, 2020
Z-0380-2021Class IIZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face,September 24, 2020
Z-0335-2021Class IIZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with SSeptember 24, 2020
Z-0323-2021Class IIZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with SSeptember 24, 2020
Z-0387-2021Class IIZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face,September 24, 2020
Z-0369-2021Class IIZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face,September 24, 2020
Z-0351-2021Class IIZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with September 24, 2020
Z-0379-2021Class IIZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face,September 24, 2020
Z-0325-2021Class IIZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with SSeptember 24, 2020
Z-0341-2021Class IIZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with SSeptember 24, 2020
Z-0388-2021Class IIZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face,September 24, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K251834Persona Partial KneeAugust 15, 2025
K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersJuly 31, 2025
K251620A.L.P.S. Proximal Humerus Plating SystemJuly 25, 2025
K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)April 18, 2025
K243293Zimmer® Persona® Personalized Knee SystemDecember 20, 2024