Recall Z-0097-2007
Conmed Corporation · initiated October 12, 2006
Product
ConMed Laparoscopic Instrument: Curved ''Maryland'' Disposable Grasper, 5mm x 33cm length, REF/Product Code 60-6045-002. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility.
Codes / lots: REF/Product Code 60-6045-002, 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.]
Reason for recall
The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-0097-2007
- Initiated
- October 12, 2006
- Posted by FDA
- October 27, 2006
- Terminated
- August 30, 2012
- Product code
- GCJ – Laparoscope, General & Plastic Surgery
- Quantity
- 83 units
- Distribution
- Worldwide
- Recalling firm
- Conmed Corporation, Utica, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0083-2007 | ConMed DetachaTip Laparoscopic Instrument: Allis Multiple Use Grasper, 5mm x 33cm…The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 10/12/2006Terminated |
| Z-0084-2007 | ConMed DetachaTip Laparoscopic Instrument: Allis Multiple Use Grasper, 5mm x 43cm…The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 10/12/2006Terminated |
| Z-0085-2007 | ConMed DetachaTip Laparoscopic Instrument: Babcock Multiple Use Grasper, 5mm x 33cm…The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 10/12/2006Terminated |
| Z-0086-2007 | ConMed DetachaTip Laparoscopic Instrument: Babcock Multiple Use Grasper, 5mm x 43cm…The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 10/12/2006Terminated |
| Z-0087-2007 | ConMed DetachaTip Laparoscopic Instrument: Curved ''Maryland'' Multiple Use Grasper, 5mm…The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 10/12/2006Terminated |
| Z-0088-2007 | ConMed DetachaTip Laparoscopic Instrument: Curved ''Maryland'' Multiple Use Grasper, 5mm…The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 10/12/2006Terminated |
| Z-0089-2007 | ConMed DetachaTip Laparoscopic Instrument: Endoweave Multiple Use Grasper, 5mm x 43cm…The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 10/12/2006Terminated |
| Z-0090-2007 | ConMed DetachaTip Laparoscopic Instrument: Fenestrated (Duckbill) Multiple Use Grasper…The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 10/12/2006Terminated |
| Z-0091-2007 | ConMed DetachaTip Laparoscopic Instrument: Meeker (Right Angle) Multiple Use Grasper…The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 10/12/2006Terminated |
| Z-0092-2007 | ConMed DetachaTip Laparoscopic Instrument: Meeker (Right Angle) Multiple Use Grasper…The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 10/12/2006Terminated |
| Z-0093-2007 | ConMed Laparoscopic Instrument: Allis Disposable Grasper, 5mm x 33cm length, REF/Product…The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 10/12/2006Terminated |
| Z-0094-2007 | ConMed Laparoscopic Instrument: Allis Disposable Grasper, 5mm x 43cm length, REF/Product…The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 10/12/2006Terminated |
| Z-0095-2007 | ConMed Laparoscopic Instrument: Babcock Disposable Grasper, 5mm x 33cm length…The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 10/12/2006Terminated |
| Z-0096-2007 | ConMed Laparoscopic Instrument: Babcock Disposable Grasper, 5mm x 43cm length…The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 10/12/2006Terminated |
| Z-0098-2007 | ConMed Laparoscopic Instrument: Curved ''Maryland'' Disposable Grasper, 5mm x 43cm…The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 10/12/2006Terminated |
| Z-0099-2007 | ConMed Laparoscopic Instrument: Endoweave Disposable Grasper, 5mm x 33cm length…The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 10/12/2006Terminated |
| Z-0100-2007 | ConMed Laparoscopic Instrument: Endoweave Disposable Grasper, 5mm x 43cm length…The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 10/12/2006Terminated |
| Z-0101-2007 | ConMed Laparoscopic Instrument: Fenestrated (Duckbill) Disposable Grasper, 5mm x 33cm…The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 10/12/2006Terminated |
| Z-0102-2007 | ConMed Laparoscopic Instrument: Fenestrated (Duckbill) Disposable Grasper, 5mm x 43cm…The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 10/12/2006Terminated |
| Z-0103-2007 | ConMed Laparoscopic Instrument: Meeker (Right Angle) Disposable Grasper, 5mm x 33cm…The company was made aware of instances where the grasper jaws broke during laparoscopic procedures. When… | 10/12/2006Terminated |
| Z-0104-2007 | ConMed Laparoscopic Instrument: Meeker (Right Angle) Disposable Grasper, 5mm x 43cm…The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 10/12/2006Terminated |
| Z-0105-2007 | ConMed Laparoscopic Instrument: Allis Disposable Dissector, 5mm x 33cm length…The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 10/12/2006Terminated |
| Z-0106-2007 | ConMed Laparoscopic Instrument: Allis Disposable Dissector, 5mm x 43cm length…The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 10/12/2006Terminated |
| Z-0107-2007 | ConMed Laparoscopic Instrument: Curved ''Maryland'' Disposable Dissector, 5mm x 33cm…The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 10/12/2006Terminated |
| Z-0108-2007 | ConMed Laparoscopic Instrument: Curved ''Maryland'' Disposable Dissector, 5mm x 43cm…The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 10/12/2006Terminated |
| Z-0109-2007 | ConMed Laparoscopic Instrument: Endoweave Disposable Dissector, 5mm x 33cm length…The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 10/12/2006Terminated |
| Z-0110-2007 | ConMed Laparoscopic Instrument: Endoweave Disposable Dissector, 5mm x 43cm length…The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 10/12/2006Terminated |
| Z-0111-2007 | ConMed Laparoscopic Instrument: Fenestrated (Duckbill) Disposable Dissector, 5mm x 33cm…The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 10/12/2006Terminated |
| Z-0112-2007 | ConMed Laparoscopic Instrument: Fenestrated (Duckbill) Disposable Dissector, 5mm x 43cm…The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 10/12/2006Terminated |
| Z-0113-2007 | ConMed Laparoscopic Instrument: Meeker (Right Angle) Disposable Dissector, 5mm x 33cm…The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 10/12/2006Terminated |