ConMed Laparoscopic Instrument: Fenestrated (Duckbill) Disposable Grasper, 5mm x 33cm length, REF/Product Code 60-6045-0
FDA device recall Z-0101-2007 · posted 2006-10-27 · Terminated
Recall details
- Recalling firm
- Conmed Corporation
- Reason for recall
- The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GCJ
- Quantity affected
- 970 units
- Distribution
- Worldwide
- Date initiated
- 2006-10-12
- Date posted
- 2006-10-27
- Date terminated
- 2012-08-30
- Location
- Utica, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CONMED SELECTONE MINIMAL ACCESS SURGERY INSTRUMENTS (K943327) | Conmedcorp | 1994-11-07 |