Events

Recall of LCP Drill Sleeve

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Synthes, 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
    79021
  • Event Risk Class
    Class 2
  • Event Number
    Z-0669-2018
  • Event Initiated Date
    2017-08-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161199
  • 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
    Guide, surgical, instrument - Product Code FZX
  • Reason
    May have difficulty attaching the drill sleeve to the plate. if the drill sleeve will not connect to the plate intraoperatively, surgical delay could occur. if the pilot hole is drilled without the drill sleeve, the pilot hole could be off-center which could result in screw and/or plate loosening.
  • Action
    In August of 2017 customers were mailed an URGENT FIELD SAFETY NOTICE titled "884115 - Locking Compression Plate (LCP) Drill Sleeve" requesting that customers who received product subject to recall to please contact: RA-DPYCH-flactionint@ITS.JNJ.com or call 610-719-5450. In the event that you have product requiring use: Pre-assemble the drill sleeve with the plate preoperatively. If you experience difficulty connecting the drill sleeve to the plate, use the additional 1.1 mm locking drill sleeve provided in the graphic case, or: o Align the 1.1 mm drill bit to the plate as perpendicular as possible and then drill freehand and the locking screw can be engaged in this manner. o If the drill hole must be used and no option to lock remains, a non-locking screw can be used.

Device

LCP Drill Sleeve
  • Model / Serial
    Lot numbers FT00227 9972971 H028400 H161606 H288454
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distribution to US, Canada, and Germany.
  • Product Description
    LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 || Used in LCP Modular Mini Fragment System, for fixation of small bones and small bone fragments
  • Manufacturer
    Synthes, Inc.

Manufacturer

Synthes, Inc.
  • Manufacturer Address
    Synthes, Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA