ConMed Laparoscopic Instrument: Meeker (Right Angle) Disposable Grasper, 5mm x 33cm length, REF/Product Code 60-6045-004
FDA device recall Z-0103-2007 · posted 2006-10-27 · Terminated
Recall details
- Recalling firm
- Conmed Corporation
- Reason for recall
- 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.
- 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
- 38 units
- Distribution
- Worldwide
- Date initiated
- 2006-10-12
- Date posted
- 2006-10-27
- Date terminated
- 2012-08-30
- Location
- Utica, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CONMED SELECTONE MINIMAL ACCESS SURGERY INSTRUMENTS (K943327) | Conmedcorp | 1994-11-07 |