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-1130-2016
  • 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=143695
  • 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
    Screw, fixation, bone - Product Code HWC
  • 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.: 61849585 61912445 61912446 61849586 61849587 61912447 61912448 61941352 61827182 61849582 62024187 62153287 61774747 61827165 61827167 61849584 61904625 61928623 62024188 62024188N 61827172 61827173 61865263 61865265 61904627 61912468 62024189 62031681 62211067 62024189N 61827157 61870904 61904626 61928624 62024190 62145270 62160893 61811070 61827193 61870905 61944998 62024191 62031682 62145271 62153288 62180565 61827151 61840634 61928627 61928628 62031639 62145272 62160895 61870906 61900329 62031646 62180567 61789465 61811156 61840635 61895711 61895713 61895714 61912679 61912682 61912691 61912694 61912695 61912699 61644731 61785346 61855921 61906705 62161934 61660596 61799289 61865276 61906699 61960093 61960095 62017439 62072611 62129843 62180552 62180552N 61660597 61865277 61865278 61936609 61936613 61963653 61988334 62017440 62027372 62040734 62112691 62138496 62142211 62328120 61660601 61799283 61799285 61835773 61865279 61906706 61936621 61936623 61981198 61981199 61981201 62009804 62027373 62086218 62097341 62112695 62198887 62258967 62027374 62027374N 61799286 61835774 61887206 61906707 61978705 61978706 62008674 62065599 62086222 62112699 62187870 62328128 61988338 61612598 61660607 61788245 61843085 61865281 61906701 61968182 61968183 62008675 62086226 62097343 62187869 62198874 62258968 61988351 62180554 61819964 61880819 61968184 62017438 62086230 62138499 62223009 61914885 62069022 61612601 61887207 61968185 62053620 62112701 62198875 61955489 62027384 61968186 62040193 62161936 61887209 61946364 62005539 62129844 62198877 61685418 61988350 62085978 61865282 61988337 62027385 62097346 61923065 62065601 61887210 61978707 62005540 62072612 61946365 62072613 61887212 61960099 61963652 62072614 62198878 62204637 62097339 61887213 61978710 62053628 62161940 61799296 62005538 61923068 62053629 62138505 62204640 62304903 62304903N 62008676 61788253 62017441 61774750 61906704 61923071 62129845 62161957 62328136 61840636 62069021 62180559 61840639 62153285 61635183 61944996 62198879 61915566 62103709 62304798 61944997 62103708 62153286 62198882 61919343 62019689 62146161 61660577 61777801 61919344 62019685 62103711 62198883 62328137 61664837 61777802 61915567 62019692 62180561 62198885 61811065 61873034 62069020 62103713 62141641 62165346 62197616 62210960 61804519 61811078 61849807 61887195 61993279 62072604 62072605 62142180 62187532 62304821 62304821N 61804520 61811152 61851962 61882672 61897689 61980116 62006416 62040561 62072606 62072607 62110004 62134893 62187535 62211064 61635186 61640832 61707780 61825947 61825949 61851966 61851968 61882676 61934178 61934182 61952701 61990341 62033050 62052729 62052731 62110006 62187537 62197617 62211065 62326527 62326527N 61804524 61804525 61825952 61825953 61825954 61851971 61867102 61887198 61897690 61897691 61934184 61934186 61980117 61980118 61990343 62006417 62006418 62065595 62072608 62072609 62072610 62110007 62134896 62134897 62160888 62187547 62204641 62223014 62258984 61640834 61750821 61754464 61789464 61825955 61839816 61851974 61867103 61882674 61887201 61919346 61919348 61934188 61974386 61974387 61990346 61999821 61999822 62052727 62052728 62065593 62097845 62097846 62097848 62103726 62160889 62160890 62165347 62197618 62204643 62239553 62354446 61764291 61764337 61764338 61839817 61851977 61867104 61867105 61887203 61919355 61919357 61934191 61993280 61993281 61999823 61999824 62080380 62080383 62110008 62110009 62160891 62176427 62204645 62258985 62304868 62304868N 61616164 61777805 61825956 61851982 61867106 61887204 61934193 61952702 61952703 61999825 61999826 62080385 62080387 62080388 62080390 62142192 62176428 62187549 62211066 62271596 61777806 61804530 61825957 61851987 61867107 61952704 61952705 61990361 62006419 62065594 62095716 62103714 62144990 62176429 61777807 61789479 61789484 61825958 61839813 61839815 61851988 61867108 61867109 61867110 61919351 61919353 61952706 61952707 61980119 61980120 61980122 62006420 62006421 62065592 62085423 62085426 62085427 62085428 62110005 62142327 62142328 62187552 62223015
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    Product 32 consists of all product under product code: HWC and same usage: || Item no: || 47115401200 HERBERT BONE SCREW, 3.0MM || 47115401400 HERBERT BONE SCREW, 3.0MM || 47115401600 HERBERT BONE SCREW, 3.0MM || 47115401800 HERBERT BONE SCREW, 3.0MM || 47115402000 HERBERT BONE SCREW, 3.0MM || 47115402200 HERBERT BONE SCREW, 3.0MM || 47115402400 HERBERT BONE SCREW, 3.0MM || 47115402600 HERBERT BONE SCREW, 3.0MM || 47115402800 HERBERT BONE SCREW, 3.0MM || 47115403000 HERBERT BONE SCREW, 3.0MM || 47115502505 HERBERT CANNULATED BONE S || 47115503005 HERBERT CANNULATED BONE S || 47115503505 HERBERT CANNULATED BONE S || 47115504005 HERBERT CANNULATED BONE S || 47115504007 HERBERT CANNULATED BONE S || 47115504505 HERBERT CANNULATED BONE S || 47115504507 HERBERT CANNULATED BONE S || 47115505005 HERBERT CANNULATED BONE S || 47115505007 HERBERT CANNULATED BONE S || 47115505505 HERBERT CANNULATED BONE S || 47115505507 HERBERT CANNULATED BONE S || 47115506005 HERBERT CANNULATED BONE S || 47115506007 HERBERT CANNULATED BONE S || 47115506505 HERBERT CANNULATED BONE S || 47115506507 HERBERT CANNULATED BONE S || 47115507005 HERBERT CANNULATED BONE S || 47115507007 HERBERT CANNULATED BONE S || 47115507505 HERBERT CANNULATED BONE S || 47115507507 HERBERT CANNULATED BONE S || 47115508005 HERBERT CANNULATED BONE S || 47115508007 HERBERT CANNULATED BONE S || 47115508505 HERBERT CANNULATED BONE S || 47115508507 HERBERT CANNULATED BONE S || 47115509005 HERBERT CANNULATED BONE S || 47115509007 HERBERT CANNULATED BONE S || 47115509505 HERBERT CANNULATED BONE S || 47115509507 HERBERT CANNULATED BONE S || 47115510005 HERBERT CANNULATED BONE S || 47115510007 HERBERT CANNULATED BONE S || 115001000 HERBERT MINI BONE SCREW 2 || 115001200 HERBERT MINI BONE SCREW 2 || 115001400 HERBERT MINI BONE SCREW 2 || 115001600 HERBERT MINI BONE SCREW 2 || 115001800 HERBERT MINI BONE SCREW 2 || 115002000 HERBERT MINI BONE SCREW 2 || 115002200 HERBERT MINI BONE SCREW 2 || 115002400 HERBERT MINI BONE SCREW 2 || 115201200 HERBERT/WHIPPLE CANN BONE || 115201400 HERBERT/WHIPPLE CANN BONE || 115201600 HERBERT/WHIPPLE CANN BONE || 115201800 HERBERT/WHIPPLE CANN BONE || 115202000 HERBERT/WHIPPLE CANN BONE || 115202200 HERBERT/WHIPPLE CANN BONE || 115202400 HERBERT/WHIPPLE CANN BONE || 115202600 HERBERT/WHIPPLE CANN BONE || 115202800 HERBERT/WHIPPLE CANN BONE || 115203000 HERBERT/WHIPPLE CANN BONE || Product Usage: || A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
  • 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