Recall Z-0111-2010 ยท MQP Spinal Vertebral Body Replacement Device
Synthes USA (HQ), Inc.
Synthes USA, TI Synex (TM) II Central Body 25mm - 33mm, Catalog number 04.808.004. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma. To be used with Synthes supplemental internal fixation system.
| Date | Nov 9, 2009 (initiated Sep 14, 2009) |
| Status | Terminated |
| Reason | loss of device height |
| Root cause | Device Design |
| Action | Synthes USA issued an "Urgent: Medical Device Recall" letter to hospital accounts, Synthes personal and sales consultants dated September 23, 2009. Users were asked to take inventory, complete and return a Verification form and return all affected product to the firm. For further information regarding the recall, contact Synthes at 1-800-479-6329 or 1-800-620-7025 extension 5453. |
| Quantity | 284 units |
| Distribution | Worldwide Distribution -- Including the United States and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003836 | SYNTHES SYNEX SPACER SYSTEM Synthes, May 29, 2001 |