Synthes (USA) Products LLC: Medical Device Recall in 2016 - (Recall #: Z-1392-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: February 18, 2016

Date Posted: April 20, 2016

Recall Number: Z-1392-2016

Event ID: 73552

Reason for Recall:

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

Status: Terminated

Product Quantity: 6 units

Code Information:

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

Distribution Pattern:

Distributed in the US: OH and ND

Voluntary or Mandated:

Voluntary: Firm initiated