Z-0493-05

VERSAPOINT, Hysteroscopic system Connector Cable, Non-Sterile, Reusable (20 uses only). US...

Name: Z-0493-05 VERSAPOINT, Hysteroscopic system Connector Cable, Non-Sterile, Reusable (20 uses only). US...
Creator: Ethicon, Inc
Published: 2004-12-16
License: https://open.fda.gov/license/

Ethicon, Inc / initiated 2004-12-16 / Terminated / root cause: manufacturing process

FDA source

Ethicon, Inc began a recall of VERSAPOINT, Hysteroscopic system Connector Cable, Non-Sterile, Reusable (20 uses only). US Distribution/Manufactured for GYNECARE, A division of Ethicon, Inc... on 2004-12-16. The reason FDA records is "Deformation of the Verspoint Hysteroscopic System Connector Cable hand grips when autoclaved causing possible non-sterile electrodes". 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-0493-05
Status: Terminated
Initiated: 2004-12-16
Posted: 2005-02-02
Terminated: 2005-10-31
Recalling firm: Ethicon, Inc
Product: VERSAPOINT, Hysteroscopic system Connector Cable, Non-Sterile, Reusable (20 uses only). US Distribution/Manufactured for GYNECARE, A division of Ethicon, Inc., a Johnson & Johnson Company, Somerville, NJ 08876. The product subject of this recall is the connector cable which goes between the electrosurgical generator and the elctrode used for surgery. Specifically, the recall focuses on the hand grip on the electrode, formed by overmolding a polymer onto the cable, which deforms upon sterilization.
Product code: HIH Hysteroscope (And Accessories)
Reason for recall: Deformation of the Verspoint Hysteroscopic System Connector Cable hand grips when autoclaved causing possible non-sterile electrodes.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The recall letter was mailed to the Director of Material Management and the Director of Operating Room on December 14, 2004.
Quantity in commerce: 891electrodes
Distribution: Ethicon distributed the devices to 166 hospitals in the US. There are no Government sales. Product sold to other countries was distributed directly from the manufacturerin England to Ethicon distributors outside the US. The Foreign countries with accounts are: Austria, Czech Republic, Greece, Italy, Benelux, Poland, Portugal, Slovenia, Spain, Sweden, France, Germany, Ireland, U.K. Canada, China, Mexico, Taiwan, Venezuela, Korea, Australia, Brazil, and India.
Product codes and lots: Product Code: 00480; Lot #s: 0404086, 0404121, 0404152, 0405010, 0405123, 0406014, 0406068, 0406130, 0407104, 0408031, 0409029, 0409080, 0410021, 0410103, 0411040.

Product code HIH

K962482Class IIScuba SystemGynecare, Inc. / cleared 1996-11-01

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)