Events

Recall of Device Recall Genesis II Oversized Nonporous FinStem Tibial Punch

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smith & Nephew 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
    36293
  • Event Risk Class
    Class 2
  • Event Number
    Z-0011-2007
  • Event Initiated Date
    2006-08-29
  • Event Date Posted
    2006-10-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-04-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48344
  • 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
    Tibial Punch - Product Code LXH
  • Reason
    Tibial punches were not manufactured to specification and could break at the tip during use.
  • Action
    Recall notification was initiated by letter (Fed Ex) to domestic territory manager and sales representative and to international distributors (via email and telephone follow-up) on 08/29/2006 to request the return of any in stock product.

Device

Device Recall Genesis II Oversized Nonporous FinStem Tibial Punch
  • Model / Serial
    Catalog Number 71927102 (Size 1-2) Lot Numbers 06AM00936, 05KM07017, 04KM18886, 04JM05040, 03FM11332, 03FM11334, 03DM01797, 02FM07372, 02CM04108, 01LM08844, 01AM16024, 00306631  Catalog Number 71927103 (Size 3-4) Lot Numbers: 06AM00937, 04LM11514, 04KM18887, 04KM12225, 04FM08554, 03FM11350, 03FM11352, 03DM01798, 02FM07387, 02CM04110, 01LM08847, 00306632  Catalog Number 71927104 (Size 5-6) Lot Numbers: 04KM15385, 04LM09224, 03FM11353, 03DM01800, 02CM04114, 01LM08850, 00306635  Catalog Number 71927105 (Size 7-8) Lot Numbers: 06AM00940, 05KM07018, 04KM18889, 04LM09225, 04FM08555, 03FM11356, 03FM11355, 03DM01803, 02CM04121, 02CM04118, 01LM08854, 01LM08852, 01HM12256, 01BM14137, 00306638
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution ----- including USA and countries of Austria, Australia, Belgium, Canada, China, Dubai, France, Germany, Italy, Japan, Malaysia, Mexico, Netherlands, Norway, Portugal, Singapore, South Africa, South Korea, Spain, Turkey, United Kingdom, and Venezuela.
  • Product Description
    Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
  • Manufacturer
    Smith & Nephew Inc

Manufacturer

Smith & Nephew Inc
  • Manufacturer Address
    Smith & Nephew Inc, 1450 E Brooks Rd, Memphis TN 38116-1804
  • Source
    USFDA