Z-1229-06

5.5 mm TRIVEX System Resector Kit (blade and tubing), 3 per box Part Number: 7209515

Name: Z-1229-06 5.5 mm TRIVEX System Resector Kit (blade and tubing), 3 per box Part Number: 7209515
Creator: Smith & Nephew, Inc. Endoscopy Division
Published: 2006-06-19
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2006-06-19 / Terminated / root cause: packaging

FDA source

Smith & Nephew, Inc. Endoscopy Division began a recall of 5.5 mm TRIVEX System Resector Kit (blade and tubing), 3 per box Part Number: 7209515 on 2006-06-19. The reason FDA records is "The sterility seal of the package trays may have incomplete seals compromising the sterility of the device". 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-1229-06
Status: Terminated
Initiated: 2006-06-19
Posted: 2006-07-13
Terminated: 2008-01-10
Recalling firm: Smith & Nephew, Inc.
Product: 5.5 mm TRIVEX System Resector Kit (blade and tubing), 3 per box Part Number: 7209515
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: The sterility seal of the package trays may have incomplete seals compromising the sterility of the device
Root cause tag: packaging
FDA root cause: Other
Action: Smith & Nephew initiated the recall by Certified Letter on June 19, 2006 requesting return of the recalled products. Smith & Nephew expanded the recall to include additional lots. The firm issued the recall expansion letter dated 8/25/06.
Quantity in commerce: 1175 units/Expanded 1674 units
Distribution: Nationwide and Austria, China, Germany, Finland, Italy, South Africa, South Korea, Switzerland, UK.
Product codes and lots: Lot Numbers: All lot numbers lower than 50165180 Expanded Recall: Lot Numbers: 50165181, 50168833, 50170484, 50170485, 50173279, 50175080, 50175934, 50175936, 50176896

Product code GEI

K990723Class IIDyonics Varicose Vein Ablation BladeSmith & Nephew, Inc. / cleared 1999-10-05

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)