Events

Recall of Zimmer Natural Nail CM Long

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

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
    72123
  • Event Risk Class
    Class 2
  • Event Number
    Z-0119-2016
  • Event Initiated Date
    2015-09-03
  • Event Date Posted
    2015-10-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139914
  • 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
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • Reason
    In about 5% of tested samples, the outer tray was found to be compromised. risks: a damaged outer tray detected during surgery may cause a delay in surgery to obtain another implant. if a compromised packaging is not detected prior or during a surgery by the user, it may lead to periprosthetic infection. this may result in revision or multi-stage revision to treat the infection.
  • Action
    On 9/3/2015, URGENT MEDICAL DEVICE RECALL notifications were sent via courier to the affected distributors and Hospital Risk Managers with instructions for locating and inspecting the affected devices and contacting Zimmer if damage is observed. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If after reviewing this notification you have questions concerning this notification, please call 1-877-946-2761.

Device

Zimmer Natural Nail CM Long
  • Model / Serial
    All Lots. Item number and name: 47-2493-481-10 ZNN CMN Nail 10mmX48cm 125 L 47-2493-442-10 ZNN CMN Nail 10mmX44cm 130 R 47-2493-480-10 ZNN CMN Nail 10mmX48cm 125 R 47-2493-445-10 ZNN CMN Nail 10mmX44cm 135 L 47-2493-483-10 ZNN CMN Nail 10mmX48cm 130 L 47-2493-444-10 ZNN CMN Nail 10mmX44cm 135 R 47-2493-482-10 ZNN CMN Nail 10mmX48cm 130 R 47-2493-441-11 ZNN CMN Nail 11.5mmX44cm 125 L 47-2493-485-10 ZNN CMN Nail 10mmX48cm 135 L 47-2493-440-11 ZNN CMN Nail 11.5mmX44cm 125 R 47-2493-484-10 ZNN CMN Nail 10mmX48cm 135 R 47-2493-443-11 ZNN CMN Nail 11.5mmX44cm 130 L 47-2493-481-11 ZNN CMN Nail 11.5mmX48cm 125 L 47-2493-442-11 ZNN CMN Nail 11.5mmX44cm 130 R 47-2493-480-11 ZNN CMN Nail 11.5mmX48cm 125 R 47-2493-445-11 ZNN CMN Nail 11.5mmX44cm 135 L 47-2493-483-11 ZNN CMN Nail 11.5mmX48cm 130 L 47-2493-444-11 ZNN CMN Nail 11.5mmX44cm 135 R 47-2493-482-11 ZNN CMN Nail 11.5mmX48cm 130 R 47-2493-441-13 ZNN CMN Nail 13mmX44cm 125 L 47-2493-485-11 ZNN CMN Nail 11.5mmX48cm 135 L 47-2493-440-13 ZNN CMN Nail 13mmX44cm 125 R 47-2493-484-11 ZNN CMN Nail 11.5mmX48cm 135 R 47-2493-443-13 ZNN CMN Nail 13mmX44cm 130 L 47-2493-481-13 ZNN CMN Nail 13mmX48cm 125 L 47-2493-442-13 ZNN CMN Nail 13mmX44cm 130 R 47-2493-480-13 ZNN CMN Nail 13mmX48cm 125 R 47-2493-445-13 ZNN CMN Nail 13mmX44cm 135 L 47-2493-483-13 ZNN CMN Nail 13mmX48cm 130 L 47-2493-444-13 ZNN CMN Nail 13mmX44cm 135 R 47-2493-482-13 ZNN CMN Nail 13mmX48cm 130 R 47-2493-421-10 ZNN CMN Nail 10mmX42cm 125 L 47-2493-485-13 ZNN CMN Nail 13mmX48cm 135 L 47-2493-420-10 ZNN CMN Nail 10mmX42cm 125 R 47-2493-484-13 ZNN CMN Nail 13mmX48cm 135 R 47-2493-423-10 ZNN CMN Nail 10mmX42cm 130 L 47-2493-463-13 ZNN CMN Nail 13mmX46cm 130 L 47-2493-422-10 ZNN CMN Nail 10mmX42cm 130 R 47-2493-461-10 ZNN CMN Nail 10mmX46cm 125 L 47-2493-425-10 ZNN CMN Nail 10mmX42cm 135 L 47-2493-460-10 ZNN CMN Nail 10mmX46cm 125 R 47-2493-424-10 ZNN CMN Nail 10mmX42cm 135 R 47-2493-463-10 ZNN CMN Nail 10mmX46cm 130 L 47-2493-421-11 ZNN CMN Nail 11.5mmX42cm 125 L 47-2493-462-10 ZNN CMN Nail 10mmX46cm 130 R 47-2493-420-11 ZNN CMN Nail 11.5mmX42cm 125 R 47-2493-465-10 ZNN CMN Nail 10mmX46cm 135 L 47-2493-423-11 ZNN CMN Nail 11.5mmX42cm 130 L 47-2493-464-10 ZNN CMN Nail 10mmX46cm 135 R 47-2493-422-11 ZNN CMN Nail 11.5mmX42cm 130 R 47-2493-461-11 ZNN CMN Nail 11.5mmX46cm 125 L 47-2493-425-11 ZNN CMN Nail 11.5mmX42cm 135 L 47-2493-460-11 ZNN CMN Nail 11.5mmX46cm 125 R 47-2493-424-11 ZNN CMN Nail 11.5mmX42cm 135 R 47-2493-463-11 ZNN CMN Nail 11.5mmX46cm 130 L 47-2493-421-13 ZNN CMN Nail 13mmX42cm 125 L 47-2493-462-11 ZNN CMN Nail 11.5mmX46cm 130 R 47-2493-420-13 ZNN CMN Nail 13mmX42cm 125 R 47-2493-465-11 ZNN CMN Nail 11.5mmX46cm 135 L 47-2493-423-13 ZNN CMN Nail 13mmX42cm 130 L 47-2493-464-11 ZNN CMN Nail 11.5mmX46cm 135 R 47-2493-422-13 ZNN CMN Nail 13mmX42cm 130 R 47-2493-461-13 ZNN CMN Nail 13mmX46cm 125 L 47-2493-425-13 ZNN CMN Nail 13mmX42cm 135 L 47-2493-460-13 ZNN CMN Nail 13mmX46cm 125 R 47-2493-424-13 ZNN CMN Nail 13mmX42cm 135 R 47-2493-462-13 ZNN CMN Nail 13mmX46cm 130 R 47-2493-401-10 ZNN CMN Nail 10mmX40cm 125 L 47-2493-465-13 ZNN CMN Nail 13mmX46cm 135 L 47-2493-400-10 ZNN CMN Nail 10mmX40cm 125 R 47-2493-464-13 ZNN CMN Nail 13mmX46cm 135 R 47-2493-403-10 ZNN CMN Nail 10mmX40cm 130 L 47-2493-441-10 ZNN CMN Nail 10mmX44cm 125 L 47-2493-402-10 ZNN CMN Nail 10mmX40cm 130 R 47-2493-440-10 ZNN CMN Nail 10mmX44cm 125 R 47-2493-405-10 ZNN CMN Nail 10mmX40cm 135 L 47-2493-443-10 ZNN CMN Nail 10mmX44cm 130 L 47-2493-404-10 ZNN CMN Nail 10mmX40cm 135 R 47-2493-401-11 ZNN CMN Nail 11.5mmX40cm 125 L 47-2493-340-10 ZNN CMN Nail 10mmX34cm 125 R 47-2493-400-11 ZNN CMN Nail 11.5mmX40cm 125 R 47-2493-343-10 ZNN CMN Nail 10mmX34cm 130 L 47-2493-403-11 ZNN CMN Nail 11.5mmX40cm 130 L 47-2493-342-10 ZNN CMN Nail 10mmX34cm 130 R 47-2493-402-11 ZNN CMN Nail 11.5mmX40cm 130 R 47-2493-341-11 ZNN CMN Nail 11.5mmX34cm 125 L 47-2493-405-11 ZNN CMN Nail 11.5mmX40cm 135 L 47-2493-340-11 ZNN CMN Nail 11.5mmX34cm 125 R 47-2493-404-11 ZNN CMN Nail 11.5mmX40cm 135 R 47-2493-343-11 ZNN CMN Nail 11.5mmX34cm 130 L 47-2493-401-13 ZNN CMN Nail 13mmX40cm 125 L 47-2493-342-11 ZNN CMN Nail 11.5mmX34cm 130 R 47-2493-400-13 ZNN CMN Nail 13mmX40cm 125 R 47-2493-341-13 ZNN CMN Nail 13mmX34cm 125 L 47-2493-403-13 ZNN CMN Nail 13mmX40cm 130 L 47-2493-340-13 ZNN CMN Nail 13mmX34cm 125 R 47-2493-402-13 ZNN CMN Nail 13mmX40cm 130 R 47-2493-343-13 ZNN CMN Nail 13mmX34cm 130 L 47-2493-405-13 ZNN CMN Nail 13mmX40cm 135 L 47-2493-342-13 ZNN CMN Nail 13mmX34cm 130 R 47-2493-404-13 ZNN CMN Nail 13mmX40cm 135 R 47-2493-321-10 ZNN CMN Nail 10mmX32cm 125 L 47-2493-381-10 ZNN CMN Nail 10mmX38cm 125 L 47-2493-320-10 ZNN CMN Nail 10mmX32cm 125 R 47-2493-380-10 ZNN CMN Nail 10mmX38cm 125 R 47-2493-323-10 ZNN CMN Nail 10mmX32cm 130 L 47-2493-383-10 ZNN CMN Nail 10mmX38cm 130 L 47-2493-322-10 ZNN CMN Nail 10mmX32cm 130 R 47-2493-382-10 ZNN CMN Nail 10mmX38cm 130 R 47-2493-321-11 ZNN CMN Nail 11.5mmX32cm 125 L 47-2493-381-11 ZNN CMN Nail 11.5mmX38cm 125 L 47-2493-320-11 ZNN CMN Nail 11.5mmX32cm 125 R 47-2493-380-11 ZNN CMN Nail 11.5mmX38cm 125 R 47-2493-323-11 ZNN CMN Nail 11.5mmX32cm 130 L 47-2493-383-11 ZNN CMN Nail 11.5mmX38cm 130 L 47-2493-322-11 ZNN CMN Nail 11.5mmX32cm 130 R 47-2493-382-11 ZNN CMN Nail 11.5mmX38cm 130 R 47-2493-321-13 ZNN CMN Nail 13mmX32cm 125 L 47-2493-381-13 ZNN CMN Nail 13mmX38cm 125 L 47-2493-320-13 ZNN CMN Nail 13mmX32cm 125 R 47-2493-380-13 ZNN CMN Nail 13mmX38cm 125 R 47-2493-323-13 ZNN CMN Nail 13mmX32cm 130 L 47-2493-383-13 ZNN CMN Nail 13mmX38cm 130 L 47-2493-322-13 ZNN CMN Nail 13mmX32cm 130 R 47-2493-382-13 ZNN CMN Nail 13mmX38cm 130 R 47-2493-301-10 ZNN CMN Nail 10mmX30cm 125 L 47-2493-361-10 ZNN CMN Nail 10mmX36cm 125 L 47-2493-300-10 ZNN CMN Nail 10mmX30cm 125 R 47-2493-360-10 ZNN CMN Nail 10mmX36cm 125 R 47-2493-303-10 ZNN CMN Nail 10mmX30cm 130 L 47-2493-363-10 ZNN CMN Nail 10mmX36cm 130 L 47-2493-302-10 ZNN CMN Nail 10mmX30cm 130 R 47-2493-362-10 ZNN CMN Nail 10mmX36cm 130 R 47-2493-301-11 ZNN CMN Nail 11.5mmX30cm 125 L 47-2493-361-11 ZNN CMN Nail 11.5mmX36cm 125 L 47-2493-300-11 ZNN CMN Nail 11.5mmX30cm 125 R 47-2493-360-11 ZNN CMN Nail 11.5mmX36cm 125 R 47-2493-303-11 ZNN CMN Nail 11.5mmX30cm 130 L 47-2493-363-11 ZNN CMN Nail 11.5mmX36cm 130 L 47-2493-302-11 ZNN CMN Nail 11.5mmX30cm 130 R 47-2493-362-11 ZNN CMN Nail 11.5mmX36cm 130 R 47-2493-301-13 ZNN CMN Nail 13mmX30cm 125 L 47-2493-361-13 ZNN CMN Nail 13mmX36cm 125 L 47-2493-300-13 ZNN CMN Nail 13mmX30cm 125 R 47-2493-360-13 ZNN CMN Nail 13mmX36cm 125 R 47-2493-303-13 ZNN CMN Nail 13mmX30cm 130 L 47-2493-363-13 ZNN CMN Nail 13mmX36cm 130 L 47-2493-302-13 ZNN CMN Nail 13mmX30cm 130 R 47-2493-362-13 ZNN CMN Nail 13mmX36cm 130 R 47-2493-305-10 ZNN CMN Nail 10mmX30cm 135 L 47-2493-341-10 ZNN CMN Nail 10mmX34cm 125 L 47-2493-305-11 ZNN CMN Nail 11.5mmX30cm 135 L 47-2493-325-10 ZNN CMN Nail 10mmX32cm 135 L 47-2493-305-13 ZNN CMN Nail 13mmX30cm 135 L 47-2493-325-11 ZNN CMN Nail 11.5mmX32cm 135 L 47-2493-365-13 ZNN CMN Nail 13mmX36cm 135 L 47-2493-325-13 ZNN CMN Nail 13mmX32cm 135 L 47-2493-344-10 ZNN CMN Nail 10mmX34cm 135 R 47-2493-304-10 ZNN CMN Nail 10mmX30cm 135 R 47-2493-344-11 ZNN CMN Nail 11.5mmX34cm 135 R 47-2493-304-11 ZNN CMN Nail 11.5mmX30cm 135 R 47-2493-344-13 ZNN CMN Nail 13mmX34cm 135 R 47-2493-304-13 ZNN CMN Nail 13mmX30cm 135 R 47-2493-364-10 ZNN CMN Nail 10mmX36cm 135 R 47-2493-324-10 ZNN CMN Nail 10mmX32cm 135 R 47-2493-364-11 ZNN CMN Nail 11.5mmX36cm 135 R 47-2493-324-11 ZNN CMN Nail 11.5mmX32cm 135 R 47-2493-364-13 ZNN CMN Nail 13mmX36cm 135 R 47-2493-324-13 ZNN CMN Nail 13mmX32cm 135 R 47-2493-385-10 ZNN CMN Nail 10mmX38cm 135 L 47-2493-345-10 ZNN CMN Nail 10mmX34cm 135 L 47-2493-385-11 ZNN CMN Nail 11.5mmX38cm 135 L 47-2493-345-11 ZNN CMN Nail 11.5mmX34cm 135 L 47-2493-385-13 ZNN CMN Nail 13mmX38cm 135 L 47-2493-345-13 ZNN CMN Nail 13mmX34cm 135 L 47-2493-384-10 ZNN CMN Nail 10mmX38cm 135 R 47-2493-365-10 ZNN CMN Nail 10mmX36cm 135 L 47-2493-384-11 ZNN CMN Nail 11.5mmX38cm 135 R 47-2493-365-11 ZNN CMN Nail 11.5mmX36cm 135 L 47-2493-384-13 ZNN CMN Nail 13mmX38cm 135 R
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide distribution.
  • Product Description
    Zimmer Natural Nail CM Long. Intramedullary Fixation Rod. || The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone.
  • Manufacturer
    Zimmer Gmbh

Manufacturer

Zimmer Gmbh
  • Manufacturer Address
    Zimmer Gmbh, Sulzer Allee 8, Winterthur Switzerland
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA