Events

Recall of Device Recall 1.5 mm RAPIDSORB Rapid Resorbable Orbital Floor Plates with Bending Template Sterile

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
    74053
  • Event Risk Class
    Class 2
  • Event Number
    Z-1920-2016
  • Event Initiated Date
    2016-05-02
  • Event Date Posted
    2016-06-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146071
  • 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, bone - Product Code JEY
  • Reason
    Labeling errors. the outer packge label expiration date may exceed the expiration date of the subcomponents.
  • Action
    DePuy Synthes sent an Urgent Medical Device Recall Notice dated May 2, 2016, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory immediately and remove the affected lots from their stock. Customers were instructed to call 1-800-479-6329 to obtain a Return Authorization (RA) Number and replacement product., customers were also asked to complete the Verification Section and scan/email to Synthes4096@stericycle.com. Customers with questions were instructed to call 610-719-5450.

Device

Device Recall 1.5 mm RAPIDSORB Rapid Resorbable Orbital Floor Plates with Bending Template Sterile
  • Model / Serial
    Catalog # 851.691.01S, Lot # 6123191, 6913455, 7540885
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution to DE, NC, CA, OK, PA, SC, WI, CO, NJ, TX, UT, IL, MO, MI, AL, KS.
  • Product Description
    1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 35 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. || Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations.
  • 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