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CRANIOS Reinforced

Synthes GmbH · Model 615.03.01S · UDI-DI 10887587058634

GXP Prescription

510(k) clearances

403

Adverse events (7 deaths)

Recalls

Facilities

Description

CRANIOS REINFORCED FAST SET PUTTY 3CC-STERILE

Recalls

Date	Firm	Reason
2021-04-01	Stryker Leibinger GmbH & Co. KG	Inability for the user to inject the paste from the syringe into the target location.
2020-04-06	Skeletal Kinetics, Llc	Bone 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
2020-04-06	Skeletal Kinetics, Llc	Bone 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
2020-04-06	Skeletal Kinetics, Llc	Bone 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
2020-04-06	Skeletal Kinetics, Llc	Bone 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
2020-04-06	Skeletal Kinetics, Llc	Bone 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
2020-04-06	Skeletal Kinetics, Llc	Bone 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
2020-04-06	Skeletal Kinetics, Llc	Bone 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
2020-04-06	Skeletal Kinetics, Llc	Bone 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
2020-04-06	Skeletal Kinetics, Llc	Bone 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.