Recall Z-0131-2011 ยท NKB Thoracolumbosacral Pedicle Screw System
Ebi, Llc
ARRAY and POLARIS Spinal System Medium Cross Connector Non Sterile Biomet Spine, Parsippany, NJ. 07054
| Date | Oct 22, 2010 (initiated Sep 16, 2010) |
| Status | Terminated |
| Reason | One of the two connector ends of the medium cross connector may not be fully secured to the rod after tightening. This may not be readily apparent to the operating surgeon, resulting in inadequate torsional stability. |
| Root cause | Other |
| Action | Biomet Spine issued an Urgent Medical Device Recall letter dated September 16, 2010 to distributors and physicians, identifying the affected device and actions to be taken. Customers and distributors were requested to identify, remove, and immediately return the affected product to Biomet, following enclosed Product Return Instructions, and complete and return the Removal Tracking and Verification Form. Customers and distributors can contact Biomet at 1-800-526-2579. |
| Quantity | 82 units |
| Distribution | Worldwide Distribution: USA and the countries of Australia, Columbia, Great Britain, The Netherlands, New Zealand, and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062685 | EBI ARAY SPINAL SYSTEM Ebi, L.P., Oct 6, 2006 |