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FDA (Device enforcement)Recalled 2024-05-29class ii

Integra LifeSciences Corp.: CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard tissue Catalog Number

Hazard

Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of treatment

Details from the source

Reason for recall: Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of treatment Distribution: Nationwide Foreign: Argentina Australia Bangladesh Bangladesh Belgium Bolivia (Plurinational State of) Brazil Canada Chile China Costa Rica Dominican Republic (the) El Salvador Hong Kong India Indonesia Japan Korea (the Republic of) Malaysia Mexico Mongolia Myanmar Nepal New Zealand Pakistan Panama Peru Philippines (the) Puerto Rico Singapore Sri Lanka Taiwan (Province of China) Thailand Viet Nam Quantity: 2, 652 units Lot/code info: UDI-DI: 10381780039419 All serial numbers distributed before 12/14/2023 Product manufactured before 11/01/2023. SN: Handpiece manufactured Prior to HAL23XXXXXXIE (represents a product that is manufactured in November 2023): HA indicating the product family Letter indicating the month of manufacture where A = January; B = February, L=November. Two digits e.g 23 indicating the year of manufacture with 23 representing 2023

UPC codes

10381780039419

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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