Events

Recall of Device Recall Graphic Case 6.5mm & 7.3mm Cannulated Screw Sets

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
    79754
  • Event Risk Class
    Class 2
  • Event Number
    Z-2245-2018
  • Event Initiated Date
    2018-03-05
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163239
  • 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
    Tray, surgical, instrument - Product Code FSM
  • Reason
    Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw length.
  • Action
    On March 8, 2018, the recalling firm sent Urgent Product Recall letters to its customers to inform them of the recall. Customers were advised to take the following actions: 1. Immediately review their inventory to identify and quarantine all affected products listed above in a manner that ensures the affected products will not be used. 2. Complete the Verification Section and send a copy to the recalling firm. 3. Forward this notice to anyone in the facility that needs to be informed. 4. If any of the affected products have been forwarded to another facility, contact that facility to arrange return. Customers with questions were advised to call 610-719-5450, 8AM-5PM (EST), Monday through Friday, or contact their DePuy Synthes sales consultant.

Device

Device Recall Graphic Case 6.5mm & 7.3mm Cannulated Screw Sets
  • Model / Serial
    FL00860
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed to accounts in CA, IL, IN, KS, LA, MD, NC, NE, NJ, OR, TX, and VA. Foreign distribution to Canada.
  • Product Description
    Part no. 690.379, Graphic Case F/6.5mm Cannulated Screw Set
  • 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