Events

Rappel de Device Recall Persona Partial Knee

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 Biomet, Inc..

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
    79383
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1238-2018
  • Date de mise en oeuvre de l'événement
    2017-11-29
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162188
  • 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, knee, femorotibial, non-constrained, cemented, metal/polymer - Product Code HSX
  • Cause
    Certain partial knee implant spacer blocks do not fit in the alignment tower instrument or handle.
  • Action
    Zimmer Biomet sent an Urgent Medical Device Correction Recall letter dated November 29, 2017. RISK MANAGER PHASE I: 1. Review this notification and notify affected personnel of the contents. 2. Product does not need to be returned at this time. You will receive a follow-up notice when the removal phase is initiated (Phase 2). If you identify a spacer block that will not assemble with these instruments, and you are unwilling to use the spacer block without this functionality, the spacer block may be returned to your sales representative. 3. Complete Certificate of Acknowledgement (Phase 1) and send to CorporateQuality.PostMarket@zimmerbiomet.com. SURGEON PHASE I: 1. Review this notification for awareness of the contents. 2. The spacer block may be used without the alignment tower and inserted and removed by hand from the joint, without the Persona Partial Knee handle. If you identify a spacer block that will not assemble with these instruments, and you are unwilling to use the spacer block without this functionality, the spacer block may be returned to your sales representative. 3. There are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule. 4. Complete Certificate of Acknowledgement (Phase 1) and send to CorporateQuality.PostMarket@zimmerbiomet.com. DISTRIBUTOR PHASE I: 1. Review this notification and notify affected team of the contents. 2. Product does not need to be returned at this time. You will receive a follow-up notice when the removal phase is initiated. 3. Should you or your account prefer to perform a functional check, this may be done by using the instructions in the surgical technique for assembling the alignment tower and handle to the spacer block. If you or your account identify a spacer block that will not assemble with these instruments, and the user is unwilling to use the spacer block without this functionality, the spacer block may be returned as a complaint to Pr

Device

Device Recall Persona Partial Knee
  • Modèle / numéro de série
    (1) 8mm block, Model Number: 42-5399-035-08, Lots: 63767442 and 63807190; (2) 9mm block, Model Number:42-5399-035-09, Lot: 63769804; (3) 10mm block, Model Number: 42-5399-035-10, Lot: 63769805; (4) 12mm block, Model Number: 42-5399-035-12, Lot: 63769806; (5) 14mm block, Model Number: 42-5399-035-14, Lots: 63767443 and 63813674
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    USA (nationwide) Distribution to the states of : AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI., and Internationally to Japan and Netherlands.
  • Description du dispositif
    Persona Partial Knee spacer block instruments; (1) 8mm block, Model Number: 42-5399-035-08; (2) 9mm block, Model Number:42-5399-035-09; (3) 10mm block, Model Number: 42-5399-035-10; (4) 12mm block, Model Number: 42-5399-035-12; (5) 14mm block, Model Number: 42-5399-035-14 || A spacer block is used to ensure the tibial resection Is sufficient and to verify limb alignment. After verification the distal femoral resecUon Is complete using the distal femoral cut slot in the spacer block. The spacer block determines how much distal femoral bone is resected.
  • Manufacturer
    Zimmer Biomet, Inc.

Manufacturer

Zimmer Biomet, Inc.
  • Adresse du fabricant
    Zimmer Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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