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ChronOS

Synthes GmbH · Model 710.014.98S · UDI-DI 10887587060798

GXPFMFLYC Prescription
2
510(k) clearances
405
Adverse events (7 deaths)
30
Recalls
39
Facilities

Description

CHRONOS(TM) BETA-TCP GRANULES 1.4-2.8MM/5.0CC-STERILE

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 time for the patient o
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 time for the patient o
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 time for the patient o
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 time for the patient o
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 time for the patient o
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 time for the patient o
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 time for the patient o
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 time for the patient o
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 time for the patient o

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.