Events

Recall of Device Recall Smith & Nephew

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

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
    73084
  • Event Risk Class
    Class 2
  • Event Number
    Z-0793-2016
  • Event Initiated Date
    2016-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-09-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143033
  • 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
    Accessories,arthroscopic - Product Code NBH
  • Reason
    Blade exhibiting fracture during hip arthroscopy procedures.
  • Action
    Smith & Nephew issued letters via Federal Express on January 11, 2016. requested to inspect inventory and locate any unused devices and quarantine them immediately. Complete Inventory Return Certification Form on the following page, indicating the quantities that need to be returned. Contact Smith & Nephews Field Action Department via email at FieldActions@smith-nephew.com or fax +1-901-566-7975 to obtain a return authorization (RA) number.

Device

Device Recall Smith & Nephew
  • Model / Serial
    Lot Codes: ( Devices within Expiry) 3009063 3009559 3010117 3010720 3011688 3012095 3012366 3014560 3016455 3018390 3020194 3022929 3025736 3027818 3030178 3032892 3036529 3071312 3071546 3074279 3074280 3076377 3076427 3085969 3089220 3093258 3098516 3101929 3104300 3107341 3111387 3114657 3115976 3119607 3123832 3124356 3124896 3125448 3128384
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution. US Nationwide and countries of AT, AU, BE, CA, CH, CL, CN, CZ, DB, DE, DK, EE, ES, FI, FR, GB, HK, IE, IL, IN, IT, JP, LT, LV, NL, NO, PL, PR, PT, RO, SE, SG, SI, TH, TR, and ZA.
  • Product Description
    Smith & Nephew BEAVER Blade 4.0mm || Part Number: 72203307 || Orthopedic surgical instrument used in hip arthroscopy.
  • Manufacturer
    Smith & Nephew, Inc.

Manufacturer

Smith & Nephew, Inc.
  • Manufacturer Address
    Smith & Nephew, Inc., 150 Minuteman Rd, Andover MA 01810-1031
  • Manufacturer Parent Company (2017)
    Smith & Nephew plc
  • Source
    USFDA