Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0091-2007

ConMed DetachaTip Laparoscopic Instrument: Meeker (Right Angle) Multiple Use Grasper, 5mm x 33cm length...

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

Conmed Corporation began a recall of ConMed DetachaTip Laparoscopic Instrument: Meeker (Right Angle) Multiple Use Grasper, 5mm x 33cm length, REF/Product Code 1-1017. --- The product is... on . The reason FDA records is "The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0091-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
ConMed Corporation
Product
ConMed DetachaTip Laparoscopic Instrument: Meeker (Right Angle) Multiple Use Grasper, 5mm x 33cm length, REF/Product Code 1-1017. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility.
Product code
GEI Electrosurgical, Cutting & Coagulation & Accessories
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
409 units
Distribution
Worldwide
Product codes and lots
REF/Product Code 1-1017, 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.]