Home / Recalls / Olympus Corporation of the Americas / Z-1167-2024

Z-1167-2024 Class II Ongoing

Recalled by Olympus Corporation of the Americas — Center Valley, PA

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;

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