Straumann USA LLC: GM Helix Acqua Implant, Article Number: 140.984

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: 300 units (125 US, 175 OUS) Lot/code info: Article Number: 140.984; UDI-DI: (01)7899878025290(11)220122(17)260121(10)JPZ21; Lot number: JPZ21;

UPC codes

7899878025290

Source

Official record: FDA (Device enforcement) ↗

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