Recall Z-2292-2013 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Ebi, Llc
Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device.
| Date | Sep 27, 2013 (initiated Apr 9, 2013) |
| Status | Terminated |
| Reason | Several complaints were recorded regarding one of the three screws driving through the cage of the Solitaire 35 implant. |
| Root cause | Process control |
| Action | Biomet LLC sent "Urgent Medical Device Recall" letters/fax back response forms on Tuesday April 9, 2013 via Fed Ex to all distributors. The notification identified the problem, product involved, and risk factors. In addition, the notification provides instructions to the representatives on how to return the product to EBI, LLC. Surgeons that have implanted the product were contacted on April 12, 2013. |
| Quantity | 1730 units |
| Distribution | Nationwide distribution: US including states of: CA, GA, IN, KY, MO, NY, OR, TX, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093629 | SOLITAIRE AND SOLITAIRE PEEK ANTERIOR SPINAL SYSTEM Biomet Spine, Mar 9, 2010 |