Synthes USA, TI Synex (TM) II Central Body 45mm - 71mm, Catalog number 04.808.007. 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.
FDA Recall Z-0114-2010 · Posted 2009-11-09
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Recalling FirmSynthes USA (HQ), Inc.
Recall StatusTerminated
Product CodeMQP
Date Initiated2009-09-14
Date Terminated2015-07-09
Product Quantity190 units
Reason for Recall
loss of device height
Firm 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.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution -- Including the United States and Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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