Events

Recall of Synthes Titanium Small Reconstruction Plate

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Synthes (USA) Products LLC.

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
    72407
  • Event Risk Class
    Class 2
  • Event Number
    Z-0236-2016
  • Event Initiated Date
    2015-10-08
  • Event Date Posted
    2015-11-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-07-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140958
  • 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
    Plate, fixation, bone - Product Code HRS
  • Reason
    The synthes sntrp set was released for sale as a trauma product in 1996 with specific trauma indications and contraindicated for certain spine applications. in 1999, a module was released containing a small offering of the sntrp plates. synthes determined that the product in the sntrp module is being used in spine surgeries, which are a contraindicated use.
  • Action
    Synthes sent an Urgent Notice Medical Device Letter dated October 8, 2015. to all affected customer. The letter identified the product the problem and the action needed to be taken by the customer. Please take the following actions: If you DO have any of the identified devices, please take the following steps: "Call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. "Complete the Verification Section at the end of this letter by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices found and note the Return Authorization Number. Please include your name, title, telephone number, and signature in the spaces provided. "Return the Verification Form (page 3 of this letter) If you DO NOT have the identified product, please take the following steps: "Complete the attached Verification Section at the end of this letter by checking the appropriate box indicating that no affected product has been located. Please include your name, title, telephone number, and signature in the spaces provided. This return documentation acknowledges your receipt of medical device removal information. "Return the documents to Synthes by: "Fax: (866) 240-5364 or "Scan/email: Synthes4642@stericycle.com If you have any questions, please call 610-719-5450 or contact your Synthes Sales Consultant. Thank you for your attention to this issue.

Device

Synthes Titanium Small Reconstruction Plate
  • Model / Serial
    Product Number Lot Number 489.401 4548779, 4545040, 4705188, 5106917 489.402 3949751 thru 6746734  A4FB851 thru A4JY300 489.403 3949753 thru 7097983  A4FB853 thru A4JV500 489.412 3950191 thru 6411381  A4FC274 thru A4JV496 489.413 3949756 thru 6819450  A4FB849 thru A4JR743 489.414 3929795 thru 6664281  A3JC152 thru A4JS596 489.415 3950185 thru 7464249  A4FB848 thru A4JS745 489.418 3949761 thru 7340734  A4FB855 thru A4JY299 489.423 3950186 thru 6714781  A4FC276 thru A4JJ712 489.424 3950189 thru 6714771  A4FB850 thru A4JV658 489.425 3173963 through 5836149   A4FC253 through A4JQ261
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution to the states of :MO, NJ, MN, MS, AZ, CA, LA, OK, VA, OH, AR, FL, PA, VT, IN, AL, WA and NY.
  • Product Description
    Synthes Small Notch Titanium Reconstructive Plate set (SNTRP). Ti PLATE/ROD/PLATE 231mm 6HOLES/5.0mm ROD/17HOLES. Orthopedic implant.
  • Manufacturer
    Synthes (USA) Products LLC

Manufacturer

Synthes (USA) Products LLC
  • Manufacturer Address
    Synthes (USA) Products LLC, 1301 Goshen Pkwy, West Chester PA 19380-5986
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA