Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Oblique Posterior Atraumatic Lumbar (OPAL) System Recalled by Synthes (USA) Products LLC Due to The label on the outer packaging does not...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Synthes (USA) Products LLC directly.
Affected Products
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.
Quantity: 6 units
Why Was This Recalled?
The label on the outer packaging does not match the product inside and intended use of the device.
Where Was This Sold?
This product was distributed to 2 states: ND, OH
About Synthes (USA) Products LLC
Synthes (USA) Products LLC has 162 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report