ConMed DetachaTip Laparoscopic Instrument: Allis Multiple Use Grasper, 5mm x 33cm length, REF/Product Code 1-1019. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility.
Hazard
The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
What You Should Do
Remedy
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.
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Products
ConMed DetachaTip Laparoscopic Instrument: Allis Multiple Use Grasper, 5mm x 33cm length, REF/Product Code 1-1019. --- The product is distributed sterile in heat-sealed tray and labeled with an expira
- Brand
- Conmed Corporation
- UPC
- REF/Product Code 1-1019, 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.]
Units Affected
955 units