Events

Recall of TWINFIX Ultra HA Suture Anchor & TWINFIX Ultra PLLA/HA Suture Anchor

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smith & Nephew, Inc. Endoscopy Division.

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
    66037
  • Event Risk Class
    Class 2
  • Event Number
    Z-2233-2013
  • Event Initiated Date
    2013-08-06
  • Event Date Posted
    2013-09-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-04-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121361
  • 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
    Fastener, fixation, biodegradable, soft tissue - Product Code MAI
  • Reason
    Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
  • Action
    Smith&Nephew; sent an Urgent Product Recall Notification letter dated August 6, 2013, via Federal Express to all affected customers. Addendum customer letters for 4 additional part numbers were sent via Federal Express on August 19, 2013, The letters identified the product, the problem, and the action to be taken by the customer. Customers were asked to inspect their inventory, locate unused devices and quarantine them. Customers were also asked to complete the last three columns in the inventory Return Certification form indicating the quantities that need to be returned, and include their contact information in the spaces provided. Customers were instructed to contact Smith & Nephew's Demo Service Departmentat 800-343-5717 for a Return Authorization (RA#), and provide the information response form. Replacement product would be provided. For questions regarding this recall call 978-749-1073.

Device

TWINFIX Ultra HA Suture Anchor & TWINFIX Ultra PLLA/HA Suture Anchor
  • Model / Serial
    50324714 50324959 50325405 50336718 50336766 50337107 50337110 50339396 50339650 50339654 50339835 50340055 50341065 50341288 50341608 50341852 50341974 50343277 50344392 50345531 50346096 50349836 50350192 50351792 50355983 50356629 50357082 50358377 50358556 50359999 50360659 50361740 50362632 50363174 50363872 50366312 50367556 50368583 50369516 50370078 50370505 50371296 50371908 50372043 50372901 50373581 50376024 50376595 50377415 50378045 50378652 50379636 50379935 50381013 50381052 50382145 50383363 50384738 50384957 50385695 50388023 50388427 50388915 50390006 50390936 50391241 50391607 50392270 50392402 50394175 50394700 50395079 50395329 50395678 50396196 50397457 50399965 50400926 50401256 50402972 50403490 50404762 50405432 50405695 50406373 50406776 50407574 50410247 50410909 50411608 50413138 50413770 50414757 50415220 50415662 50416307 50416797 50417199 50417996 50420510 50421494 50421722 50429267 50429347 50429634 50429635 50430369 50433008 50433009 50433120 50433338 50438321 50438322 50438923 50438981 50438982 50440714 50441083 50444410 50446345 50446447 50446997 50448199 50449437 50449827 50450459 50450942 50451511 50451937 50456336 50457052 50457924 50458755 50459278 50459634 50459731 50462225 50467497
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.
  • Product Description
    TWINFIX Ultra PLLA/HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black: Part Number: 72202602 || Biodegradable suture anchor
  • Manufacturer
    Smith & Nephew, Inc. Endoscopy Division

Manufacturer

Smith & Nephew, Inc. Endoscopy Division
  • Manufacturer Address
    Smith & Nephew, Inc. Endoscopy Division, 150 Minuteman Drive, Andover MA 01810-1031
  • Source
    USFDA