Events

Rappel de Device Recall Endotec Prothesis Ankle

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 Endotec, 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
    52527
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1627-2010
  • Date de mise en oeuvre de l'événement
    2009-06-05
  • Date de publication de l'événement
    2010-05-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-10-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85098
  • 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
    Prothesis Ankle - Product Code JWH
  • Cause
    Endotec is recalling b-p hip, b-p shoulder, and b-p knee replacement system devices due to sterility issues involving validation, process variations and test results.
  • Action
    Recall Letters were sent to each distributor on 06/07/2009. Questions are directed to Endotec at (407) 822-0021.

Device

Device Recall Endotec Prothesis Ankle
  • Modèle / numéro de série
    Lot No: 05010101ANN364 05010101BNN364 05010102BNN364 05010103BNN364 05010104ANN364 05010104BNN364 05010105ANN364 05010105BNN364 05010106ANN364 05010106BNN364 05020103DNN377 05020103DNN385 05020103NN377 05020104DNN377 05020104DNN385 05020105DNN376 05020105DNN385 05020113ANN377 05020114ANN377 05020123DNN377 05020123DNN385 05020124DNN377 05020124DNN385 05020125DNN376 05020125DNN385 05020143DNN377 05020143DNN385 05020145DNN385 05020163NN377 05020183DNN377 05030101BNN364 05030102BNN364 05030103BNN358 05030103BNN364 05030104A2NN364 05030104ANN364 05030104BNN358 05030104BNN364 05030105BNN364 05030106BNN364  05020106DNN376  05020115ANN376  05020116ANN376  05020126DNN376  05020146DNN376  05020165DNN376  05020166DNN376  05020185DNN376  05020186DNN376
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide distribution -- US in OH, TX, CA, FL, NJ, TN; and International Distribution: Korea, Australia, Switzerland, The Netherlands, Spain. Domestic: OH, TX, CA, FL, NJ, TN.
  • Description du dispositif
    Endotec Prothesis Ankle, Titanium Alloy, Sterilized, BP Ankle System. || BP Ankle System, B-P Type II Talar Ankle Component: || Size 1 B-P Type II Talar Ankle Component Catalog: 05-01-0101, || Size 2 B-P Type II Talar Ankle Component Catalog: 05-01-0102, || Size 3 B-P Type II Talar Ankle Component Catalog: 05-01-0103, || Size 4 B-P Type II Talar Ankle Component Catalog: 05-01-0104, || Size 5 B-P Type II Talar Ankle Component Catalog: 05-01-0105, || Size 6 B-P Type II Talar Ankle Component Catalog: 05-01-0106. || BP Ankle System, BP Type II Ankle Bearing: || 3x5mm BP Type II Ankle Bearing Catalog: 05-02-0103, || 3x6mm BP Type II Ankle Bearing Catalog: 05-02-0113, || 3x7mm BP Type II Ankle Bearing Catalog: 05-02-0123, || 3x9mm BP Type II Ankle Bearing Catalog: 05-02-0143, || 3x11mm BP Type II Ankle Bearing Catalog: 05-02-0163, || 3x13mm BP Type II Ankle Bearing Catalog: 05-02-0183, || 4x5mm BP Type II Ankle Bearing Catalog: 05-02-0104, || 4x6mm BP Type II Ankle Bearing Catalog: 05-02-0114, || 4x7mm BP Type II Ankle Bearing Catalog:05-02-0124, || 5x5mm BP Type II Ankle Bearing Catalog: 05-02-0105, || 5x7mm BP Type II Ankle Bearing Catalog: 05-02-0125, || 5x9mm BP Type II Ankle Bearing Catalog: 05-02-0145. || 5x6mm BP Type II Ankle Bearing Catalog 05-02-0106. || 6x5mm BP Type II Ankle Bearing Catalog 05-02-0115. || 6x6mm BP Type II Ankle Bearing Catalog 05-02-0116. || 7x6mm BP Type II Ankle Bearing Catalog 05-02-0126. || 9x6mm BP Type II Ankle Bearing Catalog 05-02-0146. || 11x5mm BP Type II Ankle Bearing Catalog 05-02-0165. || 11x6mm BP Type II Ankle Bearing Catalog 05-02-0166. || 13x5mm BP Type II Ankle Bearing Catalog 05-02-0185. || 13x6mm BP Type II Ankle Bearing Catalog 05-02-0186. || BP Ankle System, B-P Type II Tibial Ankle Component || Size 1 B-P Type II Tibial ankle Component Catalog: 05-03-0101, || Size 2 B-P Type II Tibial ankle Component Catalog: 05-03-0102, || Size 3 B-P Type II Tibial ankle Component Catalog: 05-03-0103, || Size 4 B-P Type II Tibial ankle Component Catalog: 05-03-0104, || Size 5 B-P Type II Tibial ankle Component Catalog: 05-03-0105, || Size 6 B-P Type II Tibial ankle Component Catalog: 05-03-0106.
  • Manufacturer
    Endotec, Inc.

Manufacturer

Endotec, Inc.
  • Adresse du fabricant
    Endotec, Inc., 2546 Hansrob Rd, Orlando FL 32804-3318
  • Société-mère du fabricant (2017)
    Cellumed Co., Ltd.
  • Source
    USFDA