Straumann USA LLC: GM Helix Acqua Implant, Article Number: 140.985

Hazard

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

Details from the source

Reason for recall: It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead. Distribution: 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. Quantity: 207 units (54 US, 153 OUS) Lot/code info: Article Number: 140.985; UDI-DI: (01)7899878024569(11)220125(17)270124(10)JPZ75; Lot number: JPZ75;

UPC codes

7899878024569

Source

Official record: FDA (Device enforcement) ↗

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