Oblique Posterior Atraumatic Lumbar (OPAL) System, Polymeric spinal fusion cage, non-sterile, OPAL Spacer 10 mm x 24…

Is this the product you have?

• 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.

Lot codes and dates

• • Lot # 9984134
  • Catalog ID 08.803.051
  • OPAL Spacer 10 mm x 24 mm
  • 11 mm Height - Revolve

Amount recalled

6 units

This recall covers 6 products

The agency filed one notice per product. You are reading one of them; the other 5 are below.

• SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura…
• SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura…
• SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura…
• SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura…
• SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura…

Where it was sold

• OH
• ND

Why it was recalled

The label on the outer packaging does not match the product inside and intended use of the device.

This product could cause temporary or reversible health problems — stop using it.