Events

Rappel de Product is OPTEFORM Allografts of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.

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 Regeneration Technologies, 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
    34004
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0482-06
  • Date de mise en oeuvre de l'événement
    2005-10-14
  • Date de publication de l'événement
    2006-02-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-07-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42941
  • 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
    Filler, Bone Void, Calcium Compound - Product Code MQV
  • Cause
    The tissue was collected from donors for whom there is no verifiable identity or consent. the medical records and social histories of the donors cannot be ascertained. the devices which incorporate these donor bone tissues undergo processing, including sterilization, which has been validated to inactivate and/or remove all viral diseases for which human tissue donors are tested.
  • Action
    Notification sent to all consignees by FedEx. 10/14/2005

Device

Product is OPTEFORM Allografts of varying sizes. Product is labeled in part: ''***Processed at:...
  • Modèle / numéro de série
    0756898 0756899 0774572 0829702 0829703 0829704 0829705 0829706 0829757 0829758 0829759 0829760 0829761 0849054 0849055 0849056 0849057 0849058 0849144 0849145 0849146 0849147 0849148 0849159 0849160 0849161 0849162 0849163 0849230 0849231 0849232 0849233 0849234 0850462 0850463 0850469 0850470 0850471 0852636 0852637 0852638 0852639 0852640 1483739 1483740 1483741 1483742 1494117 1494118 1494119 1494122 1494240 2121702 2121703 2121704 2121705 2121706 2121907 2121908 2121909 2121910 2121911 2121922 2121923 2121924 2121925 2121926 2125258 2125339 2125340 2125341 2125342 2125343 2147725 2147727 2147825 2147827 2147829 2147905 2147906 2147907 2147908 2147909 2147930 2147931 2147932 2147933 2147980 2147981 2147982 2147983 2147984 2147995 2147996 2147997 2147998 2147999 2151766 2151767 2151768 2151769 2151770 2151781 2151782 2151783 2151784 2151785 2151827 2151828 2151829 2151830 2151966 2151967 2151968 2151969 2151970 2153117 2153118 2153119 2153120 2153346 2153347 2153348 2153349 2153350 2153359 2153360 0843158 0843159 0843160 0843161 0843162 2124913 2124914 2124968 2124969 2124971 2124972 2135208 2135209 2135210 2135211 2135212 2135273 2135274 2135275 2135276 2135277 2135284 2135285 2135286 2135287 2135308 2135309 2135310 2135311 2135312 2135318 2135319 2135320 2135478 2142436 2142437 2142438 2142439 2145001 2145002 2145003 2145004 2145005 2145131 2145132 2145133 2145134 2145135 2161531 2161532 2161533 2161534 2161686 2161687 2161688 2161689 2161690 2166675 2166676 2188866 2188969 2188970 2188971 0837098 0837099 0837100 0837101 0837102 0837477 0837478 0837479 0837480 2040067 2040068 2040069 2174843 2174844 2174845 2174846 2174847 2995331 2995332 2995333 2995334 2997901 2997902 2997903 2997904 2997905 2997906 2997907 2997908 2997909 2997910
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Products were distributed worldwide.
  • Description du dispositif
    Product is OPTEFORM Allografts of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
  • Manufacturer
    Regeneration Technologies, Inc.

Manufacturer

Regeneration Technologies, Inc.
  • Adresse du fabricant
    Regeneration Technologies, Inc., 11621 Research Circle, Alachua FL 32615
  • Source
    USFDA