Z-0111-2010

Synthes USA, TI Synex (TM) II Central Body 25mm - 33mm, Catalog number 04.808.004. Intended for use in the...

Name: Z-0111-2010 Synthes USA, TI Synex (TM) II Central Body 25mm - 33mm, Catalog number 04.808.004. Intended for use in the...
Creator: Synthes USA (HQ), Inc.
Published: 2009-09-14
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2009-09-14 / Terminated / root cause: design

FDA source

Synthes USA (HQ), Inc. began a recall of 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... on 2009-09-14. The reason FDA records is "loss of device height". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0111-2010
Status: Terminated
Initiated: 2009-09-14
Posted: 2009-11-09
Terminated: 2015-07-09
Recalling firm: Synthes GmbH
Product: 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.
Product code: MQP Spinal Vertebral Body Replacement Device
Reason for recall: loss of device height
Root cause tag: design
FDA 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 in commerce: 284 units
Distribution: Worldwide Distribution -- Including the United States and Canada.
Product codes and lots: Catalog number 04.808.004 - all lots.

Product code MQP

K003836Class IISynthes Synex Spacer SystemSynthes / cleared 2001-05-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)