Recall Z-1089-2015 ยท NKB Thoracolumbosacral Pedicle Screw System
Biomet Spine, LLC
Telluride Percutaneous Rod Inserter Long, Model #7706-1904. The Inserter is a reusable device provided within an aluminum sterilization case along with other orthopedic manual surgical instruments. The case consists of three trays of instruments, and the middle tray contains a quantity of two Inserters. The Inserter is for use as part of a Telluride System pedicle screw procedure.
| Date | Feb 11, 2015 (initiated Dec 19, 2011) |
| Status | Terminated |
| Reason | The Telluride Percutaneous Rod Inserter Long does not contain a feature that locks the Rod in place during use. There is a potential for the Rod to disengage from the Inserter during insertion, and could lead to harm to the patient. |
| Root cause | Device Design |
| Action | Consignees were informally contacted 12/16/2011 of units in the field requesting retrieval. All units were in Lanx's (Biomet's) possession at the time of the recall initiation on 12/19/2011. |
| Quantity | 10 |
| Distribution | Distributed to TX, OH, NE and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.