Events

Recall of Device Recall Synthes Small Electric Drive (SED)

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
    69753
  • Event Risk Class
    Class 2
  • Event Number
    Z-0931-2015
  • Event Initiated Date
    2014-11-06
  • Event Date Posted
    2015-01-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131465
  • 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
    Pliers, surgical - Product Code HTC
  • Reason
    The device may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start. unintended start of the hand piece or wrong mode/direction could cause bone/soft tissue, peripheral nerve, and /or vascular damage. injuries may need surgical or medical intervention. surgical delay and postoperative local infection are also potential risks.
  • Action
    DePuy Synthes sent an Urgent Notice: Medical Device Removal letter dated November 6, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to notify their consignees using the hospital personnel letter, dated November 6, 2014, as their template for their consignee notification letter, review their inventory and remove the affected lots from stock. Call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number. Complete the Verification Section (page 4 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, address, telephone number and signature in the spaces provided. Return the Verification Section (page 4 of this letter) with the product to: Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132. Send a copy of the completed Verification Section to DePuy Synthes by: Fax: (610) 430-7083 or Scan/email: Fieldaction@synthes.com If you DO NOT have the identified product, please take the following steps: Complete the attached Verification Section (page 4 of this letter) by checking the appropriate box indicating that no affected product has been located. Please include your name, title, address, telephone number and signature in the spaces provided. This return documentation acknowledges your receipt of medical device removal information. Return the documents to DePuy Synthes by: Fax: (610) 430-7083 or Scan/email: Fieldaction@synthes.com Note: If the Verification Section is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual on page 4 of the notification. Customers with questions were instructed to call 610-719-5450. For questions regarding this recall call 610-719-5000.

Device

Device Recall Synthes Small Electric Drive (SED)
  • Model / Serial
    All lots of part number 05.001.175, lot numbers: 28, 40, 41, 42, 53, 105, 107, 111,  112, 113, 115.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution to Florida only
  • Product Description
    Synthes Small Electric Drive (SED), part number: 05.001.175: The Small Electric Drive is designed for use in general traumatology, especially hand and food applications involving surgical procedures such as drilling, burring, reaming, pin and wire placement, cutting of bone and hard tissue.
  • 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