Device product
Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips Ref 3221
Z-1986-2014
Product summary
- Event
- Event 68495
- Status
- Terminated
- Classification
- Class II
- Quantity
- 150 units
- Official record key
device-enforcement:Z-1986-2014
Official wording
Reason: Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw
Code information: Lot Numbers: 00115342
Distribution pattern: Worldwide Distribution-USA including the states of CA, HI, ID, MA, MI, MS, PA, TN, UT, and TX. and the countries of Belgium, France, Ireland, Germany, Indonesia, Korea, Norway, Saudi Arabia, Switzerland, Turkey, and UK.
Derived failure modes
-
Unknown
Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw