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-2222-2013
  • 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=121332
  • 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
    50272333 50272460 50272749 50273092 50274145 50274574 50277104 50277531 50278113 50281660 50283022 50283200 50283850 50285450 50287132 50290044 50290336 50292248 50293720 50295817 50298408 50301689 50302077 50305597 50307616 50307617 50307618 50307663 50308924 50308925 50308926 50309406 50309508 50310779 50311755 50312497 50314731 50316178 50316439 50317760 50318970 50320251 50320672 50321643 50321930 50322929 50324017 50325608 50326698 50327820 50329812 50331690 50332905 50334815 50336529 50339426 50340626 50341618 50343004 50343606 50344261 50344616 50346627 50350512 50351012 50351958 50353154 50353603 50354094 50355980 50356986 50358573 50359120 50360006 50360806 50361757 50362646 50363764 50364908 50364913 50364914 50370384 50372334 50372727 50372893 50374260 50375049 50375595 50378705 50378911 50379639 50380393 50380529 50383897 50384594 50385078 50385697 50387883 50388027 50388266 50389118 50390497 50392265 50394521 50395089 50395537 50397272 50397703 50399280 50400568 50401030 50401758 50402612 50403120 50403717 50404750 50405222 50406196 50407002 50407567 50407939 50408700 50409823 50411054 50412275 50413141 50414235 50415253 50415494 50416128 50416525 50417009 50417383 50418000 50418498 50419235 50421349 50423113 50423434 50425116 50426665 50426939 50427505 50429270 50430180 50431376 50433037 50433126 50434434 50435065 50435511 50438086 50438658 50439570 50440210 50441218 50442032 50444061 50444660 50445139 50445312 50445544 50445545 50446349 50447136 50448057 50449021 50449978 50449979 50449981 50449983 50449984 50449985 50450604 50450947 50451941 50452039 50453146 50453803 50454293 50454688 50455482 50455623 50456054 50456340 50456908 50458605 50460096 50460239 50461691 50462794 50463457 50466682
  • 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 2.3 mm with 1 ULTRABRAID Suture, White; Part Number: 72201991 || 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