—#48813

Product

ConMed Laparoscopic Instrument: Meeker (Right Angle) Disposable Grasper, 5mm x 43cm length, REF/Product Code 60-6045-434. --- 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 60-6045-434, 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 grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.

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 #48813. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.