Events

Recall of Device Recall Stryker Biotech

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

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
    48737
  • Event Risk Class
    Class 3
  • Event Number
    Z-2311-2008
  • Event Initiated Date
    2008-06-24
  • Event Date Posted
    2008-09-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-10-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72023
  • 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, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction - Product Code MPW
  • Reason
    Product package insert misprint-text offset.
  • Action
    Stryker Biotech notified by letter dated June 24, 2008 via UPS Certified Mail. Physician letters were mailed 30 Jun 2008 and IRB letters were mailed July 01, 2008; letters included a correctly printed package insert. Contact Judith Sernatinger at 508-416-5200 if you have questions.

Device

Device Recall Stryker Biotech
  • Model / Serial
    Lots Numbers: FC0803004, FC0803005, FC0804002, FC0804007, FCO804010, FC0805002, FC0805003, and FC0805004
  • Product Classification
    Orthopedic Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Stryker Biotech OP- 1 Implant is indicated for use as an alternative to autograft in recalcitrant long bone nonunions where use of autograft is unfeasible and alternative treatments have failed. || Catalog Number: 100-25
  • Manufacturer
    Stryker Biotech

Manufacturer

Stryker Biotech
  • Manufacturer Address
    Stryker Biotech, 35 South St, Hopkinton MA 01748-2218
  • Source
    USFDA