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.
FDA Recall Z-1392-2016 · Posted None
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Recalling FirmSynthes (USA) Products LLC
Recall StatusTerminated
Product CodeMAX
Date Initiated2016-02-18
Date Terminated2016-11-08
Product Quantity6 units
Reason for Recall
The label on the outer packaging does not match the product inside and intended use of the device.
Firm Action
DePuy Synthes sent an Urgent Notice letter dated February 18, 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review inventory, immediately remove the affected lots from their stock and complete the attached Verification Section. For questions call 610-719-5450 or contact your DePuy Synthes Sales Consultant
Root Cause
Labeling mix-ups
Distribution Pattern
Distributed in the US: OH and ND
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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