Events

Recall of Device Recall Depuy Mitek LupineLoopPlus Anchor w/Orthocord DS

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

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
    61088
  • Event Risk Class
    Class 2
  • Event Number
    Z-1166-2012
  • Event Initiated Date
    2012-01-27
  • Event Date Posted
    2012-03-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107273
  • 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
    Lupine br anchor w/ orthocord may be assembled with an incorrect suture configuration and result in a loose repair.
  • Action
    DePuy Mitek sent an Urgent Voluntary Product Recall letter dated January 27, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to immediately check all inventories to determine if they have any affected product. Customers were asked to refer to the instructions to report their inventory status, return and obtain replacement or credit for the product. For questions regarding this recall call 1-877-379-4871.

Device

Device Recall Depuy Mitek LupineLoopPlus Anchor w/Orthocord DS
  • Model / Serial
    Lot Numbers: 3254891 3255034 3263566 3265788 3271667 3274014 3275848 3278854 3280530 3285983 3291737 3292679 3301541 3303082 3307441 3310874 3314468 3316690 3317375 3318420 3320462 3324467 3325365 3329112 3335908 3342267 3342269 3345993 3349577 3352888 3365987 3369756 3374558 3377520 3381940 3386941 3387259 3395185 3396187 3396396 3401431 3401638 3403914 3406629 3406968 3413445 3414931 3415168 3418983 3420848 3431721 3433230 3434054 3435821 3438965 3442446 3449646 3452857 3455281 3470842 3476093 3477803 3484272 3487119 3489688 3494965 3496820 3504366 3504853 3510568 3515580 3519667 3529351 3532090 3538865 3544392 3549732 3551001 3554778 3557175 3558965 3560275 3562226 3570372
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Canada, AE, Argentina, Australia, Austria,Belgium,Brazil, Bahrain, Chile, China, Columbia,Cyprus, Check Republic, Germany, Denmark, Ecuador, Egypt, Spain, Finland, France, Finland, Great Britain, Guadeloupe, Hong Kong, Hungary,Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Luxembourg,Latvia, Martinique, Montenegro, Mexico, Maylasia, Netherlands,Norway, New Zealand, Oman, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Sweden, Singapore, Slovakia, Thailand, Tunisia, Turkey,Uruguay, Venezuela, and South Africa
  • Product Description
    Depuy Mitek LupineLoopPlus Anchor w/Orthocord DS || Catalog Number: 210709 || The Lupine Anchor System is indicated for use in soft tissue bone fixation.
  • Manufacturer
    DePuy Mitek, Inc., a Johnson & Johnson Co.

Manufacturer

DePuy Mitek, Inc., a Johnson & Johnson Co.
  • Manufacturer Address
    DePuy Mitek, Inc., a Johnson & Johnson Co., 325 Paramount Dr, Raynham MA 02767
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA