Recalls / —
—#48812
Product
ConMed Laparoscopic Instrument: Meeker (Right Angle) Disposable Grasper, 5mm x 33cm length, REF/Product Code 60-6045-004. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility.
- FDA product code
- GCJ — Laparoscope, General & Plastic Surgery
- Device class
- Class 2
- Medical specialty
- Gastroenterology, Urology
- 510(k) numbers
- K943327
- Affected lot / code info
- REF/Product Code 60-6045-004, 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.]
Why it was recalled
The company was made aware of instances where the grasper jaws broke during laparoscopic procedures. When the grasper jaws had broken they had done so at the junction of the jaw and the tube. In no instances was it reported to the company that small pieces had broken off of the grasper jaws.
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
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.
Recalling firm
- Firm
- Conmed Corporation
- Address
- 525 French Road, Utica, New York 13502-5945
Distribution
- Distribution pattern
- Worldwide
Timeline
- Recall initiated
- 2006-10-12
- Posted by FDA
- 2006-10-27
- Terminated
- 2012-08-30
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #48812. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.