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Recall Observatory FDA recall evidence

Device product

Plus Initial Drill, Article Number: 103.170;

Z-1861-2025

April 14, 2025

Class II

Product summary

Firm
Straumann USA LLC
Event
Event 96798
Status
Ongoing
Classification
Class II
Quantity
288 units ($& US, 241 OUS)
Official record key
device-enforcement:Z-1861-2025

Official wording

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

Code information: Article Number: 103.170; UDI-DI: (01)7898237561967(11)250204(17)400204(10)LNWT8; Lot Number: LNWT8

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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