Events

Recall of SRS FAST SET PUTTY 3 CC BONE VOID FILLERSTERILE

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

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
    60051
  • Event Risk Class
    Class 2
  • Event Number
    Z-0460-2012
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-12-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104316
  • 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
    A recent shipment carrying norian srs was lost by the carrier. since the product was lost before final product release testing, synthes is unable to confirm that part number srs-005-fsp- lot number n001101 meets final product release requirements. the product contains all final labeling and cannot be visually distinguished from the product that has met final product release requirements.
  • Action
    All Synthes accounts with a history of purchasing the product in the past two years will be notified by letter of the incident. All firm sales consultants will also receive written notification of the incident.

Device

SRS FAST SET PUTTY 3 CC BONE VOID FILLERSTERILE
  • Model / Serial
    Part Number SRS-005-FSP, Lot number N001101
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Synthes USA sent a "NOTICE: MISSING SHIPMENT-NORIAN SRS" letter dated September 29, 2011 to all accounts with a history of purchasing the product in the past two years. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to check their inventory to verify they have not received the affected product. Call 1-800-620-7025 ext. 5450 for questions concerning this notice.
  • Product Description
    SRS FAST SET PUTTY 3 CC BONE VOID FILLER-STERILE, Part Number SRS-005-FSP, Lot number N001101. || Bone void filler.
  • Manufacturer
    Synthes USA

Manufacturer

Synthes USA
  • Manufacturer Address
    Synthes USA, 1230 Wilson Dr, West Chester PA 19380-4231
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA