Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1433-06

ConMed DetachaTip Multi-Use Laparoscopic Instrument - "Fenestrated (Duckbill) Multiple Use Grasper", 5 mm x...

ConMed Corporation / initiated 2006-03-27 / Terminated

Conmed Corporation began a recall of ConMed DetachaTip Multi-Use Laparoscopic Instrument - "Fenestrated (Duckbill) Multiple Use Grasper", 5 mm x 33 cm, REF/Product code-1-1008. ------- The product... on . The reason FDA records is "Grasper jaws breaking at the junction of the jaw and tube during laparoscopic procedures". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1433-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
ConMed Corporation
Product
ConMed DetachaTip Multi-Use Laparoscopic Instrument - "Fenestrated (Duckbill) Multiple Use Grasper", 5 mm x 33 cm, REF/Product code-1-1008. ------- 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
Grasper jaws breaking at the junction of the jaw and tube during laparoscopic procedures.
FDA root cause
Other
Action
On 3/27/06, all domestic customers were sent an "URGENT DEVICE RECALL" notice, dated 3/27/06, by USPS Priority Mail (Delivery Confirmation). International customers were notified by facsimile and/or e-mail as well as by mail.
Quantity in commerce
5205 units
Distribution
Worldwide
Product codes and lots
Product Code: 1-1008; all lot codes manufactured between 10/20/2003 and 2/16/2005. Each lot code is found on the package labeling of unopened units and is also embossed on the grey hub of the device. For 5 digit lot codes: the 1st digit represents the year (4 represents 2004), the 2nd & 3rd digits represent the month (09 for September), and the 4th & 5th digits for the day of the month. For 7 digit lot codes: the 1st two digits represent the year, the 3rd & 4th represent the month, the 5th & 6th represent the day of the month, and the 7th digit represents the manufacturing shift code.