Events

Rappel de Device Recall Flower Orthopedics Variable Angle Locking Peg

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 Flower Orthopedics Corporation.

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
    70578
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1314-2015
  • Date de mise en oeuvre de l'événement
    2015-02-16
  • Date de publication de l'événement
    2015-03-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-08-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134073
  • 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
    Locking pegs were not locking during distal radius procedures. there has been one (1) report of revision surgery scheduled to remove a loosened peg.
  • Action
    On February 16, 2015, Flower Orthopedics generated and distributed a field memo/advisory notice (FOCMB-15-02) to all distributors with locking peg inventory on February 6, 2015. The field memo provided technique guidance to end users. All 12 consignees with remaining inventory (ie.not reported as used) were contacted directly via phone and all have agreed to ship the locking pegs back to Flower Orthopedics. Flower Orthopedics determined that a generic statement to all customers was not necessary for the following reasons detailed above and summarized again here: product was distributed only through direct channels, the health hazard evaluation has determined there is a very low risk to health, and all consignees have been directly contacted already and product inventory is being returned.

Device

Device Recall Flower Orthopedics Variable Angle Locking Peg
  • Modèle / numéro de série
    All lots of Catalog Numbers:  FLP 114, FLP 116, FLP 118, FLP 120, FLP 122, FLP 124, FLP 126
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Distributed in the states of VA, TX, IL, OK, PA, CA, NY, KY, and FL.
  • Description du dispositif
    Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D:1.8mm x L:16.0mm, Variable Angle Locking Peg, D:1.8mm x L:18.0mm; Variable Angle Locking Peg, D:1.8mm x L:20.0mm; Variable Angle Locking Peg, D:1.8mm x L:22.0mm, Variable Angle Locking Peg, D:1.8mm x L:24.0mm; Variable Angle Locking Peg, D:1.8mm x L:26.0mm. || The locking pegs are intended to be used in conjunction with the Flower Orthopedics Distal Radius Plate for osteosynthesis of the radius bone.
  • Manufacturer
    Flower Orthopedics Corporation

Manufacturer

Flower Orthopedics Corporation
  • Adresse du fabricant
    Flower Orthopedics Corporation, 100 Witmer Rd Ste 280, Horsham PA 19044-2647
  • Société-mère du fabricant (2017)
    Flower Orthopedics Corp.
  • Source
    USFDA