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FDA (Device enforcement)Recalled 2025-04-14class ii

Straumann USA LLC: Plus Initial Drill, Article Number: 103.170;

Hazard

The referred batch was produced without the laser engraving of 7 mm.

Details from the source

Reason for recall: The referred batch was produced without the laser engraving of 7 mm. Distribution: Worldwide - US Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, MN, NC, NV, NY, OH, OK, SC, TX, VA, WI and the countries of Brazil, Germany, India, Indonesia, Portugal, Romania, Spain, Switzerland, Ukraine. Quantity: 288 units ($& US, 241 OUS) Lot/code info: Article Number: 103.170; UDI-DI: (01)7898237561967(11)250204(17)400204(10)LNWT8; Lot Number: LNWT8

UPC codes

7898237561967

Source

Official record: FDA (Device enforcement)

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

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