Device product
Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips (Reusable) Ref 3222
Z-1987-2014
Product summary
- Event
- Event 68495
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6290 units
- Official record key
device-enforcement:Z-1987-2014
Official wording
Reason: Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw
Code information: Lot Numbers: Lot Number 00115282 Lot Number 00115283 Lot Number 00115284 Lot Number 00115340 Lot Number 00115341 Lot Number 00115501 Lot Number 00115502 Lot Number 00115865 Lot Number 00116277 Lot Number 00116278
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