Recall Z-1392-2016— Synthes (USA) Products LLC

Name: FDA recall Z-1392-2016
Creator: U.S. Food and Drug Administration
Published: 2016-02-18

Class II · Terminated

Class II FDA medical device recall by Synthes (USA) Products LLC, initiated 2016-02-18, terminated 2016-11-08. It names one FDA 510(k) clearance: K072791. Product: 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.. Reason: The label on the outer packaging does not match the product inside and intended use of the device..

Recalling firm: Synthes (USA) Products LLC
Classification: Class II
Status: Terminated
Initiated: 2016-02-18
Terminated: 2016-11-08
Firm location: West Chester, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K072791 — ORACLE SPACER, OPAL SPACERSynthes Spine·cleared 2007-12-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.