Z-1212-06

Product is Reprocessed Ethicon Bladeless Trocars. Model: 35NLT, 35NST, 35OL

Name: Z-1212-06 Product is Reprocessed Ethicon Bladeless Trocars. Model: 35NLT, 35NST, 35OL
Creator: Vanguard Medical Concepts, Inc
Published: 2006-03-17
License: https://open.fda.gov/license/

Stryker Sustainability Solutions / initiated 2006-03-17 / Terminated / root cause: packaging

FDA source

Vanguard Medical Concepts, Inc began a recall of Product is Reprocessed Ethicon Bladeless Trocars. Model: 35NLT, 35NST, 35OL on 2006-03-17. The reason FDA records is "Review of complaints and testing show that the distal tip of the trocars may separate while in use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1212-06
Status: Terminated
Initiated: 2006-03-17
Posted: 2006-07-12
Terminated: 2008-10-31
Recalling firm: Stryker Sustainability Solutions
Product: Product is Reprocessed Ethicon Bladeless Trocars. Model: 35NLT, 35NST, 35OL
Product code: NLM Laparoscope, General & Plastic Surgery, Reprocessed
Reason for recall: Review of complaints and testing show that the distal tip of the trocars may separate while in use.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: The firm sent recall notification letters to its consignees on 3-17-2006. They were instructed to discontinue use of the 35NLT, 35NST and 35Ol Reprocessed Optiview Trocars with expiration date of 12/20008 or earlier immediately. Any of this product in inventory were to be returned to the manufacturer for credit. The firm also offered the assistance of its representatives in returning all affected profucts. The investigation is ongoing, and corrective actions associated with the root cause of tips breaking off have been identified and are being implemented.
Quantity in commerce: 13,842
Distribution: Nationwide.
Product codes and lots: All lot numbers produced before January, 1, 2006. (Product with expiration date of 12/20008 or earlier.)

Product code NLM

K043253Class IIVanguard Reprocessed Dilating Tip and Blunt TrocarsVanguard Medical Concepts, Inc. / cleared 2005-04-08

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)