Events

Recall of Device Recall AlloFuse DBM Putty 5cc

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by AlloSource, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    67986
  • Event Risk Class
    Class 2
  • Event Number
    Z-1562-2014
  • Event Initiated Date
    2014-03-25
  • Event Date Posted
    2014-05-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-08-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126738
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Filler, bone void, calcium compound - Product Code MQV
  • Reason
    The donor was hemodiluted.
  • Action
    AlloSource sent letter via USPS Certified Mail Receipt to all affected customers dated March 25, 2014, and March 26, 2014. The letter identified the product the problem and the action needed to be taken by the customer. AlloSource requested that the distributor consignee notify subsequent consignees to determine disposition and to request return of unused product. Returned inventory will be quarantined physically and electronically upon receipt. Product initially quarantined and product returned will be destroyed following established procedures. Further questions please call (720) 873-4733

Device

Device Recall AlloFuse DBM Putty 5cc
  • Model / Serial
    Lot numbers 132095-603, 608, 609, 611-618, 622-629, 631-634, and 636-638. Lot numbers 132095-604, 619, and 621.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distribution US nationwide, including Michigan and a distributor in Colorado.
  • Product Description
    AlloFuse DBM Putty 5cc, Catalog No. 90038005 || AlloFuse is indicated for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. AlloFuse is indicated to be packed gently into bony gaps in the skeletal system as a bone graft extender.
  • Manufacturer
    AlloSource, Inc.

Manufacturer

AlloSource, Inc.
  • Manufacturer Address
    AlloSource, Inc., 6278 S Troy Cir, Centennial CO 80111-6422
  • Manufacturer Parent Company (2017)
    Allosource
  • Source
    USFDA