Device product
ESG PK CUTTING FORCEPS, 5MM, 33CM
Z-1167-2024
Product summary
- Event
- Event 93842
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 11,123 units
- Official record key
device-enforcement:Z-1167-2024
Official wording
Reason: The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure.
Code information: Model: PK-CF0533; UDI DI: 00821925035867; Lot Numbers: FR258486, FR261738, FR259544, FR263183, FR276278, FR279757, FR279625, FR279658, FR286369, FR287112, FR374622, FR207935, FR212413, FR212735, FR215061, FR216817, FR220525, FR222456, FR227254, FR227774, FR227781, FR232882, FR234845, FR247614, FR240430, FR246627, FR247039, FR248008, FR255679, FR248312, FR263636, FR263244, FR269280, FR269267, FR269269, FR287114, FR303799, FR297022, FR301062, PWO-308561, PWO-308562, PWO-308563, PWO-308560, PWO-308567, PWO-308566, PWO-308565, FR303864, FR313639, FR316869, FR319703, FR316872, FR327890, PWO-308972, FR335984, FR335990, FR337947, FR373912, FR401646, FR379790, FR347006;
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Australia, Canada, Germany, Mexico, P.R. China, Singapore, South Korea.
Derived failure modes
-
Unknown
The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure.