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Osteostrip

OSTEOPORE INTERNATIONAL PTE. LTD. · Model PC17(100,2,4) · UDI-DI 08885013200409

GXP Prescription

510(k) clearances

403

Adverse events (7 deaths)

Recalls

Facilities

Description

Dimensions: 100 x 2 x 4 mm Material: PCL Intended Use: The Osteopore PCL Scaffold Bone Filler is intended for use in the repair of neurosurgical burr holes, craniotomy cuts and other cranial defects. It is also for use in the augmentation or restoration of bony contour in the craniofacial skeleton. It should be gently packed into bony voids or gaps of the skeletal system.

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.