Synthes USA (HQ), Inc. Synthes USA, TI Synex (TM) II Central Body 58mm - 84mm, Catalog number 04.808.008. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Synthes USA, TI Synex (TM) II Central Body 58mm - 84mm, Catalog number 04.808.008. 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.
Brand
Synthes USA (HQ), Inc.
Lot Codes / Batch Numbers
Catalog number 04.808.008 - all lots.
Products Sold
Catalog number 04.808.008 - all lots.
Synthes USA (HQ), Inc. is recalling Synthes USA, TI Synex (TM) II Central Body 58mm - 84mm, Catalog number 04.808.008. Intended for use due to loss of device height. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
loss of device height
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026