Events

Rappel de Device Recall Zimmer

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Zimmer Manufacturing B.V..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    72900
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1101-2016
  • Date de mise en oeuvre de l'événement
    2016-01-11
  • Date de publication de l'événement
    2016-03-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-04-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143628
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
  • Cause
    As a result of the insufficient sealer calibration data for product packaged in firm's building ii between august 2010 and april 2013. the affected products are sterile.
  • Action
    Zimmer Biomet sent an Urgent Medical Device Recall Letter, dated January 11, 2016, to Distributors, Sales Representatives, Operation Managers, and Risk Managers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to 1.Review the notification and ensure that relevant personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative with the quarantine of any affected product. 3. Your Zimmer Biomet sales representative will remove the recalled product from your facility. 4. Complete and return the attached Certificate of Acknowledgment form to corporatequality.postmarket@zimmerbiomet.com. 5. If after reviewing this notification you have further questions or concerns please call Customer Service at 1-800-348-2759, or contact your Zimmer Biomet Sales Representative.

Device

Device Recall Zimmer
  • Modèle / numéro de série
    lot no.62097104 62207231 62219224 62340091 62340091N 61643437 62268552 62340092 62340092N 61679532 61928512 62340093 62340093N 61885911 61885912 61885913 61957517 62182418 62219225 62240286 61885914 61885915 61947602 62134035 62182412 62188330 62240287 62340096 62340096N 61633850 61633854 62138595 62240289 62240809 62322617 62322617N 61545831 61630163 61986626 62240291 62329068 62329068N 61664534 61847124 61923939 62134030 62142871 62175266 62180219 62199414 62199415 62211996 62216689 62234491 62249032 62249033 62322611 62334011 62322611N 62334011N 61630305 61847131 61947598 61952494 62100692 62151857 62203217 62216691 62216692 62240302 62240810 62240811 62334008 62334008N 370550 61947601 61987197 62222767 62235720 62332949 62332950 62332949N 62332950N 61825735 61856097 62175257 62211992 62275064 61658071 61947594 62260133 62334010 62334010N 61847130 61987198 62175263 62194590 62215697 62240814 62240815 62266498 62334002 62334002N 61882247 61891121 61953143 61966580 62065323 62140350 62333999 62333999N 61575673 62097102 62112174 62216690 62284346 62079945 61567514 61899124 61899125 61899126 61900614 61953163 61953164 62125310 62178695 62182839 62186365 62188290 62189402 62194575 62194576 62195515 62197292 62199391 62207223 62208752 62255219 62262673 62303511 62305939 62312480 62312481 62315850 62315851 62339012 62339013 62339014 62364761 62364762 62364763 62381462 62381463 62383206 62383308 62384251 62384252 62384253 62389775 62389776 62389777 62389779 62396405 62396482 62396483 62396484 62303511N 62305939N 62312480N 62312481N 62315850N 62315851N 61589036 61589038 61593808 62188291 62189400 62299081 62312482 62322469 62339015 62381465 62389780 62396485 62299081N 62312482N 62322469N 62076892 62125313 62172046 62189401 62315853 62364760 62315853N
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    Product 3 consists of all products under product code JDI, and same usage: || Item no:781803800 12/14 UNIPOLAR FEMORAL HE || 781804000 12/14 UNIPOLAR FEMORAL HE || 781804100 12/14 UNIPOLAR FEMORAL HE || 781804200 12/14 UNIPOLAR FEMORAL HE || 781804300 12/14 UNIPOLAR FEMORAL HE || 781804400 12/14 UNIPOLAR FEMORAL HE || 781804500 12/14 UNIPOLAR FEMORAL HE || 781804600 12/14 UNIPOLAR FEMORAL HE || 781804700 12/14 UNIPOLAR FEMORAL HE || 781804800 12/14 UNIPOLAR FEMORAL HE || 781804900 12/14 UNIPOLAR FEMORAL HE || 781805000 12/14 UNIPOLAR FEMORAL HE || 781805100 12/14 UNIPOLAR FEMORAL HE || 781805200 12/14 UNIPOLAR FEMORAL HE || 781805300 12/14 UNIPOLAR FEMORAL HE || 781805400 12/14 UNIPOLAR FEMORAL HE || 781805500 12/14 UNIPOLAR FEMORAL HE || 781806300 12/14 UNIPOLAR FEMORAL HE || 781809900 12/14 UNIPOLAR FEMORAL HE || 781809901 12/14 UNIPOLAR FEMORAL HE || 781809902 12/14 UNIPOLAR FEMORAL HE || Product For use in total or hemi hip arthroplasty
  • Manufacturer
    Zimmer Manufacturing B.V.

Manufacturer

Zimmer Manufacturing B.V.
  • Adresse du fabricant
    Zimmer Manufacturing B.V., Turpeaux Industrial Park Rd 1 km 123.4, Mercedita PR 00715
  • Société-mère du fabricant (2017)
    Zimmer Biomet Holdings
  • Commentaire du fabricant
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA