Z-0096-2007

ConMed Laparoscopic Instrument: Babcock Disposable Grasper, 5mm x 43cm length, REF/Product Code 60-6047-431...

Name: Z-0096-2007 ConMed Laparoscopic Instrument: Babcock Disposable Grasper, 5mm x 43cm length, REF/Product Code 60-6047-431...
Creator: Conmed Corporation
Published: 2006-10-12
License: https://open.fda.gov/license/

ConMed Corporation / initiated 2006-10-12 / Terminated / root cause: manufacturing process

FDA source

Conmed Corporation began a recall of ConMed Laparoscopic Instrument: Babcock Disposable Grasper, 5mm x 43cm length, REF/Product Code 60-6047-431. --- The product is distributed sterile in... on 2006-10-12. The reason FDA records is "The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube". 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-0096-2007
Status: Terminated
Initiated: 2006-10-12
Posted: 2006-10-27
Terminated: 2012-08-30
Recalling firm: ConMed Corporation
Product: ConMed Laparoscopic Instrument: Babcock Disposable Grasper, 5mm x 43cm length, REF/Product Code 60-6047-431. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility.
Product code: GEJ Carrier, Ligature
Reason for recall: The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 10/12/06, ConMed sent "URGENT DEVICE RECALL" packages (letter dated 10/11/06) to the domestic accounts via UPS Ground, and via UPS Express for the International accounts. Devices are to be removed from use and returned.
Quantity in commerce: 32 units
Distribution: Worldwide
Product codes and lots: REF/Product Code 60-6047-431, all lot codes manufactured between 08/25/2003 and 03/24/2005. [Lot codes on unopened boxes and packaging contain a lot code in the following form: for example 0409271 - 04 represents the year 2004, 09 represents the month of the year, 27 represents the day of the month, and the last digit 1 represents the manufacturing shift code. Lot codes are located on the device in this form: for example 40927 - 4 represents the year 2004, 09 represents the month of the year, and 27 represents the day of the month.]

Product code GEJ

K943327Class IIConmed Selectone Minimal Access Surgery InstrumentsConmedcorp / cleared 1994-11-07

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)