Recall Z-0108-2010
Synthes USA (HQ), Inc. · initiated September 14, 2009
Product
Synthes USA, TI Synex (TM) II Central Body 14mm - 19mm, Catalog number 04.808.001. 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.
Codes / lots: Catalog number 04.808.001 - all lots.
Reason for recall
loss of device height
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-0108-2010
- Initiated
- September 14, 2009
- Posted by FDA
- November 9, 2009
- Terminated
- July 9, 2015
- Product code
- MQP – Spinal Vertebral Body Replacement Device
- Quantity
- 267 units
- Distribution
- Worldwide Distribution -- Including the United States and Canada.
- Recalling firm
- Synthes USA (HQ), Inc., West Chester, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0109-2010 | Synthes USA, TI Synex (TM) II Central Body 17mm - 25mm, Catalog number 04.808.002.…loss of device height | 09/14/2009Terminated |
| Z-0110-2010 | Synthes USA, TI Synex (TM) II Central Body 21mm - 29mm, Catalog number 04.808.003.…loss of device height | 09/14/2009Terminated |
| Z-0111-2010 | Synthes USA, TI Synex (TM) II Central Body 25mm - 33mm, Catalog number 04.808.004.…loss of device height | 09/14/2009Terminated |
| Z-0112-2010 | Synthes USA, TI Synex (TM) II Central Body 29mm - 44mm, Catalog number 04.808.005.…loss of device height | 09/14/2009Terminated |
| Z-0113-2010 | Synthes USA, TI Synex (TM) II Central Body 37mm - 52mm, Catalog number 04.808.006.…loss of device height | 09/14/2009Terminated |
| Z-0114-2010 | Synthes USA, TI Synex (TM) II Central Body 45mm - 71mm, Catalog number 04.808.007.…loss of device height | 09/14/2009Terminated |
| Z-0115-2010 | Synthes USA, TI Synex (TM) II Central Body 58mm - 84mm, Catalog number 04.808.008.…loss of device height | 09/14/2009Terminated |
| Z-0116-2010 | Synthes USA, TI Synex (TM) II Central Body 71mm - 97mm, Catalog number 04.808.009.…loss of device height | 09/14/2009Terminated |
| Z-0117-2010 | Synthes USA, TI Synex (TM) II Central Body 84mm - 110mm, Catalog number 04.808.010.…loss of device height | 09/14/2009Terminated |
| Z-0118-2010 | Synthes USA, TI Synex (TM) II Central Body 97mm - 123mm, Catalog number 04.808.011.…loss of device height | 09/14/2009Terminated |