Device Recall Oblique Posterior Atraumatic Lumbar (OPAL) System

  • Modèle / numéro de série
    Lot # 9984134, Catalog ID 08.803.051, OPAL Spacer 10 mm x 24 mm, 11 mm Height - Revolve
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    Distributed in the US: OH and ND
  • Description du dispositif
    Oblique Posterior Atraumatic Lumbar (OPAL) System, Polymeric spinal fusion cage, non-sterile, OPAL Spacer 10 mm x 24 mm, 11 mm Height - Revolve || Product Usage - The OPAL Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the OPAL Spacer should be packed with autogenous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months or non-operative treatment. The OPAL Spacer is intended to be used with Synthes supplemental fixation, e.g. TSLP, ATB, Antegra, Pangea, USS Including ClickX) and small stature USS.
  • Manufacturer
  • 1 Event


  • Adresse du fabricant
    Synthes (USA) Products LLC, 1301 Goshen Pkwy, West Chester PA 19380-5986
  • Société-mère du fabricant (2017)
  • Source