Events

Recall of Osteoraptor 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-2221-2013
  • 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=121331
  • 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
    Staple, fixation, bone - Product Code JDR
  • 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

Osteoraptor Suture Anchor
  • Model / Serial
    50272329 50272466 50274208 50274464 50274790 50275814 50277799 50278266 50278994 50282166 50283019 50283839 50285057 50286656 50288421 50289813 50291359 50293118 50294563 50295608 50296649 50298065 50301017 50302318 50305467 50306821 50308347 50309211 50310089 50310614 50311296 50312591 50314389 50315223 50315419 50316180 50316679 50316987 50317481 50318376 50318532 50319543 50320363 50321935 50323084 50323631 50324184 50324789 50327218 50331339 50333094 50336659 50339177 50340628 50343607 50345140 50345975 50347750 50349688 50352034 50352998 50354277 50354523 50356122 50356984 50357948 50358554 50360002 50360656 50361750 50362641 50363887 50364918 50367858 50368809 50370314 50371912 50374779 50375720 50376835 50377822 50379209 50381376 50384165 50385364 50386748 50387839 50388736 50390940 50392275 50393329 50394520 50395793 50397073 50399277 50400560 50401454 50402073 50403117 50403703 50404630 50406026 50407298 50408207 50408986 50409815 50410646 50411754 50413578 50414258 50415462 50416319 50417212 50418095 50418678 50420659 50422216 50428378 50429372 50429659 50430185 50430406 50433943 50435810 50436716 50437246 50438205 50438744 50440212 50440606 50441444 50443360 50443860 50444062 50445142 50445316 50445551 50445552 50445553 50445555 50445556 50447139 50448325 50449126 50450279 50451524 50452588 50452764 50453646 50454691 50455485 50456543 50458419 50458609 50460107 50460693 50463955 50464113 50465465 50468475
  • 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
    OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue ; Part Number: 72201995 || 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