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Recall Observatory FDA recall evidence

Device product

GM Helix Acqua Implant, Article Number: 140.985

Z-1863-2025

May 01, 2025

Class II

Product summary

Firm
Straumann USA LLC
Event
Event 96806
Status
Ongoing
Classification
Class II
Quantity
207 units (54 US, 153 OUS)
Official record key
device-enforcement:Z-1863-2025

Official wording

Reason: It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.

Code information: Article Number: 140.985; UDI-DI: (01)7899878024569(11)220125(17)270124(10)JPZ75; Lot number: JPZ75;

Distribution pattern: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, Il KS, LA, MA, MD, MI, NE, NH, NJ, NY, OH, OK, RI, SC, TN, TX, UT, WI and the countries of Australia, Croatia, France, Hungary, India, Italy, Lebanon, Lithuania, New Zealand, Portugal, Qatar, Serbia, Spain, Tunisia, UAE, United Kingdom, Vietnam.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.