Events

Recall of 2.0 MM DRILL BIT

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
    61767
  • Event Risk Class
    Class 2
  • Event Number
    Z-1715-2012
  • Event Initiated Date
    2012-04-13
  • Event Date Posted
    2012-06-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108963
  • 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
    Bit, drill - Product Code HTW
  • Reason
    Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
  • Action
    Smith & Nephew Sales Representatives and Smith & Nephew International Distributors were notified of the problem with the affected product and the recall via email on April 13, 2012. All affected direct consignees were notified via Fed Ex on April 13, 2012. The Urgent Medical Device Recall letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to cease use and distribution of the product and quarantine them immediately for return. Customers were instructed to complete the Inventory Return Certification Form included with the letter. Customers should fax or email the form to 901-566-7975 or fieldactions@smith-nephew.com. The affected product should be returned to: Smith & Nephew Attn: Global Field Actions Safety Affairs 1450 Brooks Road Memphis, Tennessee 38116 If the affected product was distributed further customers were instructed to provide a copy of the recall letter to these customers.

Device

2.0 MM DRILL BIT
  • Model / Serial
    Lot Numbers: 07BHU0004E, 07CHU0010E, 07DHU0025D, 07DHU0025E, 07LHU0004J, 07LHU0004K, 07LHU0004L, 07LHU0004M ,08AHU0004J, 08BHU0019G, 08BM20807A, 08CHU0016G, 08CHU0018F, 08FM15736B, 08JHU0008B, 08LHU0020G, 08MHU0026C, 09BHU0031E, 09BHU0031F, 09BHU0031G, 09CHU0044D, 09DHU0019, 09DHU0019B, 09DHU0036, 09DHU0036C, 09DHU0036D, 09DHU0036E, 09DHU0036F, 09EHU0003, 09EHU0003A, 09EHU0003B, 09EHU0003C, 09EHU0003D, 09EHU0003E, 09EHU0003F, 09EHU0007, 09EHU0007A, 09EHU0007B, 09EHU0007C, 09EHU0007D, 09EHU0013, 09EHU0013A, 09EHU0013B, 09EHU0013C, 09EHU0013D, 09EHU0013E, 09EHU0013F, 09FHU0005, 09FHU0005A, 09FHU0033, 09FHU0033B, 09FHU0033C, 09FHU0033D, 09FHU0033F, 09FHU0033G, 09FHU0033H, 09GM06174A, 09GM14035, 09HHU0008, 09HHU0010, 09HHU0010A, 09HHU0010B, 09HHU0010C, 09HHU0010D, 09HHU0010E, 09HHU0010F, 09HM12199, 09HM12202, 09HM17431, 09KHU0001, 09KHU0001A, 09KHU0001B, 09KHU0001C, 09KHU0001D, 09KHU0001E, 09KHU0001G, 09KHU0001H, 09KHU0001P, 09KHU0010, 09KHU0010A, 09KHU0010B, 09LM10792, 09MM01112A, 10AM02971, 10BHU0007, 10BHU0007A, 10BHU0007B, 10BHU0007C, 10BHU0007D, 10BHU0007F, 10BHU0007G, 10BHU0010, 10BHU0010A, 10BHU0010M, 10BHU0018, 10BHU0018A, 0BHU0018B, 10BHU0018C, 10BHU0018D, 10BHU0018E, 10BHU0018F, 10EHU0013, 10EHU0013A, 10EHU0013B, 10FM16220, 11CHU0015A, 11CHU0015B, 11CHU0015C, 11DHU0003, 11DHU0003A, 11DHU0005, 11DHU0005A, 11DHU0005B, 11HHU0027, 11HHU0030, 11HHU0031, 11HHU0031B, 11HHU0032, 11HHU0034, 11JHU0006, 11JHU0007, 11JHU0008, 11JHU0009, 11JHU0010, 11JHU0024, 11JHU0024A, 11KHU0007, 11KHU0016, 11LHU0004, 11LHU0005, 11LHU0005A, 11LHU0007, 11LHU0008, 11LHU0011, 11LHU0011A, 11LHU0012, 11LHU0027, 11LHU0027A, 11LHU0027C, 11LHU0027X, 11LHU0034, 11LHU0035, 11MHU0005, 11MHU0005A, 11MHU0005D, 1MHU0017, 11MM11935, 11MNG0008, 11MNG0008A, 11MNG0008B, 11MNG0009, 11MNG0009A, 11MNG0009C, 11MNG0018, 11MNG0018D, 11MNG0018E, 11MNG0025, 11MNG0025N, 11MNG0025P, 12AHU0001, 12AHU0001B, 12AHU0001C, 12AHU0014, 12BHU0010, 12BHU0010B, 12BHU0011, 12BHU0011A, 12BHU0025, 12BHU0025A, 12BHU0025B, 12BHU0025E, 12BHU0025G, 477420-14A
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Malaysia, Germany, Japan, Portugal, United Arab Emirates, Spain, France, South Africa, Norway, Sweden, Denmark, Switzerland, Belgium, China, The Netherlands, Finland, Mexico, Italy, UK, Venezuela, Colombia, Thailand, Chile, South Korea, India, and Turkey
  • Product Description
    2.0 MM DRILL BIT, REF 71173501, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 || Orthopedic surgical device.
  • Manufacturer
    Smith & Nephew Inc

Manufacturer

Smith & Nephew Inc
  • Manufacturer Address
    Smith & Nephew Inc, 1450 E. Brooks Rd, Memphis TN 38116
  • Manufacturer Parent Company (2017)
    Smith & Nephew plc
  • Source
    USFDA