Z-0414-2007

AutoSuture Bladed Trocar, equipped with safety shield. Model number 179094. Available with smooth or threaded...

Name: Z-0414-2007 AutoSuture Bladed Trocar, equipped with safety shield. Model number 179094. Available with smooth or threaded...
Creator: Ascent Healthcare Solutions, Inc.
Published: 2006-10-19
License: https://open.fda.gov/license/

Stryker Sustainability Solutions / initiated 2006-10-19 / Terminated / root cause: manufacturing process

FDA source

Ascent Healthcare Solutions, Inc. began a recall of AutoSuture Bladed Trocar, equipped with safety shield. Model number 179094. Available with smooth or threaded sleeve in sizes 5-15mm inner diameter and... on 2006-10-19. The reason FDA records is "The tip of the trocars may separate before and while in use. In some instances the trocars have been found with exposed blades upon opening the packaging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0414-2007
Status: Terminated
Initiated: 2006-10-19
Posted: 2007-02-08
Terminated: 2008-10-31
Recalling firm: Stryker Sustainability Solutions
Product: AutoSuture Bladed Trocar, equipped with safety shield. Model number 179094. Available with smooth or threaded sleeve in sizes 5-15mm inner diameter and 70-100mm length.
Product code: NLM Laparoscope, General & Plastic Surgery, Reprocessed
Reason for recall: The tip of the trocars may separate before and while in use. In some instances the trocars have been found with exposed blades upon opening the packaging.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: The recall was initiated on 10/19/2006 by direct distribution of the recall notice to direct accounts by the firm's sales force. The firm also posted the notification on their web site. All customers were instructed to examine their inventories for the product and to remove and quarantine all affected product. Instructions on returning the product to the firm were also included along with a response form.
Quantity in commerce: 1566
Distribution: Nationwide
Product codes and lots: 94724 95261 104057 94853 95272 104217 94893 100062 104335 94894 102389 104337 94897 102394 104343 94953 102681 104584 94957 102851 105517 94962 103100 94964 103103 95024 103200 95026 103288 95029 103293 95069 103297 95135 103566 95259 103570

Product code NLM

K043594Class IIVanguard Reprocessed Bladed Trocar, Non-Bladed Trocar, Trocar AccessoriesVanguard Medical Concepts, Inc. / cleared 2005-03-31

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)