Events

Rappel de Device Recall Stryker AccuLIF PL Cages

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 Howmedica Osteonics Corp..

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
    74931
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2788-2016
  • Date de mise en oeuvre de l'événement
    2016-07-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-03-12
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148849
  • 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
    Intervertebral fusion device with bone graft, lumbar - Product Code MAX
  • Cause
    Since stryker acquired the acculif product in march of 2014, there have been product inquires (pis) related to the pl implant confirming to have a reduction of height > 1 mm. the current occurrence rate for reported post-operative reduction of cage height (> 1mm) of acculif pl expandable cages is approximately 0.47% and has demonstrated a slight upward trend since september 2015.
  • Action
    Stryker Spine sent an "Urgent Recall Letter and Product Accountability Form" dated July 26, 2016 to all affected customers. For patients who have had an AccuLIF Posterior Lumbar (PL) Expandable Interbody implant, Stryker Spine is recommending routine clinical and radiographic post-operated evaluation. Should the patient report any change in or develop near-onset symptoms, more urgent clinical and radiographic evaluation should be completed. Customers with questions should call 201-749-8389 or 201-749-8346.

Device

Device Recall Stryker AccuLIF PL Cages
  • Modèle / numéro de série
    Catalog #400010 Lot #'s 01021403, 01121508, 01121509, 01271515, 01271516, 02021512, 02021513, 02021514, 02021515, 02021602, 03221310, 04141508, 04141509, 04141510, 04141511, 04141512, 04251312, 06101405, 06101406, 06101407, 06251311, 07011406, 07201510, 07201511, 07201512, 08141303, 08141313, 09251504, 09281512, 10081301, 10081302, 10201502, 10201503, 10301504, 11121514, 11121518, 11121521, 12151511 and 12151517
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    NationwideDistribution
  • Description du dispositif
    AccuLIF PL 10-16mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for intervertebral body fusion with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Additionally, the AccuLIF PL Cages can be used as in adjunct to fusion in patients diagnosed with degenerative scoliosis. The AccuLIF Pl Cages are always to be used with supplemental internal spinal fixation. Additionally, the AccuLIF PL Cages are to be used with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion
  • Manufacturer
    Howmedica Osteonics Corp.

Manufacturer

Howmedica Osteonics Corp.
  • Adresse du fabricant
    Howmedica Osteonics Corp., 2 Pearl Ct, Allendale NJ 07401-1611
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA