Recall Z-1392-2016 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Synthes (USA) Products LLC
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 t
| Date | Feb 18, 2016 |
| Status | Terminated |
| Reason | The label on the outer packaging does not match the product inside and intended use of the device. |
| Root cause | Labeling mix-ups |
| 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 |
| Quantity | 6 units |
| Distribution | Distributed in the US: OH and ND |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072791 | ORACLE SPACER, OPAL SPACER Synthes Spine, Dec 26, 2007 |