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-1139-2016
  • 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=143749
  • 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
    Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
  • 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.: 61644212 61792526 61815349 61828043 61850984 61890427 61921816 61934581 61969233 62017629 62093240 62093241 62093243 62171309 62197649 62197650 62299114 62318135 62318136 62318137 62318138 62318150 61644213 61815350 61828044 61873638 61934582 62002277 62067293 62075869 62160328 62213281 62263054 62263055 62267127 62267128 62267129 62267130 62267131 62267133 62267135 62267136 62267137 62267138 62267139 62267140 62294218 62294225 62294226 62294228 61803056 61873639 61895894 61912747 61912749 62227211 62299118 62299127 62299132 62299134 61764436 62213282 62322533 62322535 62322537 62322612 62322616 62322620 62322623 62322637 62227216 62322865 62322866 62322867 62322868 62322870 62322871 62322875 62322881 62322883 62322885 62322881N 62322881P 61982440 62054519 62075872 37107680 62338654 62338655 62058551 62075873 61897704 62054521 62124276 62218067 61786382 62002271 62067291 62075871 62263052 61644206 61828034 61858125 61921813 61982441 62054523 62054524 62075870 62213267 62263057 62263058 62263060 62263062 62311830 62311838 62213267N 61629787 61644207 61700053 61815343 61878336 61906727 61982442 62031691 62067292 62172859 62172863 62172866 62172869 62172875 62172881 62285701 62285703 62285704 62285705 62285706 62285707 62285719 62285735 62285736 62285737 62293594 62293596 62293598 62293601 62293603 62293604 37107683 61644208 61658563 61700054 61815344 61828036 61858129 61890423 61906729 61964352 62031692 62085434 62171298 62171299 62172882 62172883 62172901 62172902 62172903 62172922 62172924 62311864 62311865 62311867 62311868 62317534 62317535 61644209 61666067 61774943 61792524 61803051 61828037 61849828 61849829 61890424 61906732 61906734 61921814 61951257 61951258 61982444 62002272 62002273 62171301 62219423 62219424 62219425 61644210 61700056 61774945 61774946 61774949 61782868 61792525 61815347 61815348 61828039 61850979 61858126 61890425 61897705 61921815 61934577 61934578 61951259 61951260 62002275 62002276 62031695 62037785 62037786 62037787 62146201 62171303 62171304 62213272 62219426 62227191 62253341 62253342 62253343 62253358 62253360 62054520 61774950 61774951 61798414 61798417 61798418 61803052 61803053 61828041 61850980 61850981 61873634 61873635 61890426 61897706 61906723 61906725 61951261 61951262 62017624 62017625 62017626 62031698 62095808 62171307 62197644 62197645 62213280 62219427 62240213 62240216 62240218 62240221 62240223 62240224 62318171 62318172 62318173 62318176 62318177 62318180 62318182 62318183 62318185 62318186 62318188 62318189 62318191 62318193 61644211 61666114 61686799 61700058 61774953 61774958 61798423 61803054 61803055 61828042 61850982 61858127 61873637 61897707 61934579 61951263 61964353 62008238 62017627 62090097 62090099 62090101 62146213 62197646 62197647 62227192 62227193 61780306 61977803 62054525 62106378 61951264 62090102 62157180 62093248 62171310 61927737 61969231 62031700 61969232 62137458 61815351 61878377 62141642 61815352 62046412 62165416
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    Product 41 consists of all product under product code: KTT and same usage: || Item no: || 119301042 LAG SCR 12.7D X 100MM STA || 119301045 LAG SCR 12.7D X 105MM STA || 119301047 LAG SCR 12.7D X 110MM STA || 119301050 LAG SCR 12.7D X 115MM STA || 119301052 LAG SCR 12.7D X 120MM STA || 119301055 LAG SCR 12.7D X 125MM STA || 119301057 LAG SCR 12.7D X 130MM STA || 119301060 LAG SCR 12.7D X 135MM STA || 119301062 LAG SCR 12.7D X 140MM STA || 119301070 LAG SCR 12.7D X 155MM STA || 119301020 LAG SCR 12.7D X 55MM STAN || 119301022 LAG SCR 12.7D X 60MM STAN || 119301025 LAG SCR 12.7D X 65MM STAN || 119301027 LAG SCR 12.7D X 70MM STAN || 119301030 LAG SCR 12.7D X 75MM STAN || 119301032 LAG SCR 12.7D X 80MM STAN || 119301035 LAG SCR 12.7D X 85MM STAN || 119300537 LAG SCR 12.7D X 90MM SHOR || 119301037 LAG SCR 12.7D X 90MM STAN || 119301040 LAG SCR 12.7D X 95MM STAN || 119301542 LAG SCR 15.8D X 100MM LAR || 119301545 LAG SCR 15.8D X 105MM LAR || 119301547 LAG SCR 15.8D X 110MM LAR || 119301550 LAG SCR 15.8D X 115MM LAR || 119301552 LAG SCR 15.8D X 120MM LAR || 119301555 LAG SCR 15.8D X 125MM LAR || 119301557 LAG SCR 15.8D X 130MM LAR || 119301520 LAG SCR 15.8D X 55MM LARG || 119301522 LAG SCR 15.8D X 60MM LARG || 119301525 LAG SCR 15.8D X 65MM LARG || 119301532 LAG SCR 15.8D X 80MM LARG || 119301535 LAG SCR 15.8D X 85MM LARG || 119301537 LAG SCR 15.8D X 90MM LARG || Product Usage: || Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached 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