Oblique Posterior Atraumatic Lumbar System recalled over sterility concerns

Recall date

February 18, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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

Recall number

Z-1392-2016

FDA classification

Class II

Brand / firm

Synthes (USA) Products LLC

Sold / distributed

Distributed in the US: OH and ND

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.