Skip to content

Synthes USA, TI Synex (TM) II Central Body 17mm - 25mm… recallZ-0109-2010 · Synthes USA (HQ), Inc. · initiated Sep 14, 2009

Terminated All recalls posted in November 2009

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Synthes USA (HQ), Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

loss of device height

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-0109-2010
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Sep 14, 2009
Posted by the FDA
Nov 9, 2009
Recalling firm
Synthes USA (HQ), Inc.
Quantity
272 units
Product code
MQP
FDA submissions
K003836
Distribution
Worldwide Distribution -- Including the United States and Canada.

Product description

Synthes USA, TI Synex (TM) II Central Body 17mm - 25mm, Catalog number 04.808.002. 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.

Code information (models, lots, serial numbers)

Catalog number 04.808.002 - all lots.

Other devices under the same FDA submission

4 devices cleared under K003836 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 53509).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page