Events

Recall of Device Recall SROM Noiles Rotating Hinge Femur with Pin

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by DePuy Orthopaedics, 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
    67627
  • Event Risk Class
    Class 2
  • Event Number
    Z-1205-2014
  • Event Initiated Date
    2014-02-24
  • Event Date Posted
    2014-03-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125864
  • 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
    Prosthesis, knee, femorotibial, constrained, cemented, metal/polymer - Product Code KRO
  • Reason
    Depuy orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for s-rom¿ noiles rotating hinge femur with pin devices. the outer carton and shrink wrap are intact. a package redesign is underway to resolve this issue. s-rom noiles rotating hinge femur with pin devices will remain in us distributors inventory during the p.
  • Action
    DePuy Orthopaedics sent an Urgent Information - Recall Notice dated February 24, 2014, to all affected customers. The notice identified the product, reason for the recall and potential risks associated with using the recalled product. The notice includes response cards for the US Distributors to verify they have read, understood, and are adhering to the directions given in the field communication and for hospitals where consignment inventory is removed a hospital letter is available, as needed. No hospital signatures are required. Distributors are asked to send completed distributor cards to DePuy. Product related questions should be addressed to DePuy Orthopaedics, .Sales Consultant. Clinical questions should be addressed to DePuy Scientific Information Office 1-888-554-2482; recall questions to 574-371-4917.

Device

Device Recall SROM Noiles Rotating Hinge Femur with Pin
  • Model / Serial
    E1VHS4, 430482, 338164, 373256, 395802, 409578, 448220, 409582, 238688, 430483, 306508, 329330, 264451, 448222, 216275, 373255, 346439, 409580, 338165, 250929, 360638, D65FJ4, 216277, 395804, EJ7F14, 254740, 302815, FF8DW4, 314821, 464642, 338166, FA4FP4, FA4FT4, 238411LC, 464643, 278448, 409579, 464640, 395803, 088411LA, 308248, FF8DX4, 196411LA, 448227, C1VCE4, 402352, 346437, 366433, 238687, 172188, 329332, 250931, 464641, 216274, 302813, 295384, 264453, 337411LA, 120084, 236445, 289043, 329331, 308247, and 395806
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Canada, Australia, Austria, China, Czech Republic, Denmark, Dubai / UAE, Estonia, France, Germany, Hungary, Iberia, India, Ireland, Israel, Italy, Malaysia, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Russia, Singapore, Slovenia, Spain, South Africa, Sweden, Switzerland, Turkey, United Kingdom, and Vietnam.
  • Product Description
    REF 623411 L, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, Small, Sterile R || Qty 1 || The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures, but are present almost all the time.
  • Manufacturer
    DePuy Orthopaedics, Inc.

Manufacturer

DePuy Orthopaedics, Inc.
  • Manufacturer Address
    DePuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA