inforMED

GRAFTON ORTHBLEND SMALL DEFECT

Received May 31, 2012 · Event occurred May 3, 2012

Report 2618041 · MDR key 2618041

Device

Generic name

Bone Tissue

Manufacturer

Osteotech

Model number

*

Catalog number

P44150

Lot number

OTSCT1004954091

Product problems

  • Nonstandard Device
  • Contamination /Decontamination Problem

Patient

57 YR

  • No Information

Narrative

Description of Event or Problem

RECALL FROM MANUFACTURER REGARDING QUESTIONS ABOUT STERILITY. ITEM IMPLANTED AFTER RECALL NOTICE ISSUED BY COMPANY.