Z-1167-2024 Class II Ongoing
FDA device recall Z-1167-2024 was initiated by Olympus Corporation of the Americas on December 15, 2023 and is designated Class II. Reason for recall: The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure. The recall status is ongoing. Affected quantity: 11,123 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 28, 2024
- Initiation Date
- December 15, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,123 units
Product Description
ESG PK CUTTING FORCEPS, 5MM, 33CM
Reason for Recall
The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Australia, Canada, Germany, Mexico, P.R. China, Singapore, South Korea.
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;