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Methyl Methacrylate For Cranioplasty

FDA product code GXP · Class 2 · Neurology

279
Registered devices
405
Adverse events
30
Recalls
45
510(k) clearances

Devices with this code

Osteomesh — OSTEOPORE INTERNATIONAL PTE. LTD.IPS — KLS-Martin L.P.IPS — KLS-Martin L.P.IPS — KLS-Martin L.P.OsteoVation — SKELETAL KINETICS LLCSKaffold — SKELETAL KINETICS LLCCRANIOS Reinforced — Synthes GmbHStaGraft DBM Plus — Biomet Orthopedics, LLCCRANIOSCULPT-C — DIMENSIONAL BIOCERAMICS LLCALLOGENIX — BIOMET MICROFIXATION, INCIPS — KLS-Martin L.P.SKaffold — SKELETAL KINETICS LLCIPS — KLS-Martin L.P.IPS — KLS-Martin L.P.Osteoplug — OSTEOPORE INTERNATIONAL PTE. LTD.Osteoplug — OSTEOPORE INTERNATIONAL PTE. LTD.IPS — KLS-Martin L.P.IPS — KLS-Martin L.P.IPS — KLS-Martin L.P.IPS — KLS-Martin L.P.Osteomesh — OSTEOPORE INTERNATIONAL PTE. LTD.IPS — KLS-Martin L.P.IPS — KLS-Martin L.P.CRANIOS Reinforced — Synthes GmbH

Recent recalls

DateFirmReason
2021-04-01Stryker Leibinger GmbH & Co. KGInability for the user to inject the paste from the syringe into the target location.
2020-04-06Skeletal Kinetics, LlcBone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia ti
2020-04-06Skeletal Kinetics, LlcBone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia ti
2020-04-06Skeletal Kinetics, LlcBone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia ti
2020-04-06Skeletal Kinetics, LlcBone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia ti
2020-04-06Skeletal Kinetics, LlcBone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia ti
2020-04-06Skeletal Kinetics, LlcBone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia ti
2020-04-06Skeletal Kinetics, LlcBone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia ti
2020-04-06Skeletal Kinetics, LlcBone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia ti
2020-04-06Skeletal Kinetics, LlcBone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia ti

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.