Events

Recall of Ruggles Leyla Ball Joint Clamp

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by J. Jamner Surgical Instruments, 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
    36031
  • Event Risk Class
    Class 3
  • Event Number
    Z-1506-06
  • Event Initiated Date
    2006-04-24
  • Event Date Posted
    2006-09-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-09-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47762
  • 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
    Ball joint clamp - Product Code FWZ
  • Reason
    The ruggles¿ leyla ball joint clamp may not properly tighten onto the rigid holding rod. although this condition can be observed during assembly, if the device were to be used during surgery, any attachments to the rigid holding rod could move.
  • Action
    On 4/24/06, Integra LifeSciences Corp. sent an 'URGENT - RECALL NOTICE' letter (dated 4/24/06) and a 'RECALL ACKNOWLEDGEMENT' Form to the 5 hospitals and 1 salesman that received the product.

Device

Ruggles Leyla Ball Joint Clamp
  • Model / Serial
    The affected product can be identified by the following code on the product label: 143 60173 6.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    5 hospitals in MS, IL, WI and TX, and 1 salesman in IL.
  • Product Description
    Ruggles¿ Leyla Ball Joint Clamp, MODEL/CATALOG #: R2383 . The Leyla Ball Joint Clamp is part of the Table Mounting Hardware that is used with the Leyla Retractor System. The Leyla Table Mounting Hardware consists of the Ball Joint Clamp, the Rigid Holding Rod, the Coupling Head, and the Coupling Head Turn Table. The Ball Joint Clamp is available individually or as part of the Table Mount Set. The Table Mounting Hardware are attachments to operating room surgical tables. The product is supplied non-sterile and may be packaged individually or as part of the Table Mount Set.
  • Manufacturer
    J. Jamner Surgical Instruments, Inc.

Manufacturer

J. Jamner Surgical Instruments, Inc.
  • Manufacturer Address
    J. Jamner Surgical Instruments, Inc., 9 Skyline Drive, Hawthorne NY 10532-2100
  • Source
    USFDA