Device product
Retractor f/Sciatic Nerve Long; Part number: 03.100.014; UDI: 10886982070630
Z-1759-2018
Product summary
- Event
- Event 79850
- Status
- Terminated
- Classification
- Class II
- Quantity
- 196
- Official record key
device-enforcement:Z-1759-2018
Official wording
Reason: There is a potential for microspores to form on the hollow handle of the Sciatic Nerve Retractor. The pores may increase in size, allowing fluid to enter the hollow handle.
Code information: Lot numbers: T104993, T108115, T114598, T140566, T140665, T140670, T140671, T140673, T141540, T143687, T144854, T145585, T145590, T145932, T146657, T147929, T148552, T148553, T149727, T149728 T151369, T151488, T152808, T152809, T153884, T155649, T958061
Distribution pattern: US Nationwide and Canada
Derived failure modes
-
Unknown
There is a potential for microspores to form on the hollow handle of the Sciatic Nerve Retractor. The pores may increase in size, allowing fluid to enter the hollow handle.