Straumann USA LLC: Device Recall

Recall #Z-1863-2025 · 05/01/2025

Class II: Risk

Recall Details

Recall Number: Z-1863-2025
Classification: Class II
Product Type: Device
Recalling Firm: Straumann USA LLC
Status: Ongoing
Date Initiated: 05/01/2025
Location: Andover, MA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 207 units (54 US, 153 OUS)

Reason for Recall

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

Product Description

GM Helix Acqua Implant, Article Number: 140.985

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.

Other Recalls by Straumann USA LLC

Class II: Risk 10/17/2025

The possibility for this product that is intended for demonstration purposes only to be placed in patients.
Class II: Risk 05/01/2025

It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
Class II: Risk 04/17/2025

Incorrect blister labelling.
Class II: Risk 04/14/2025

The referred batch was produced without the laser engraving of 7 mm.
Class II: Risk 03/08/2025

The devices are missing the laser marked depth markings.

View all recalls by Straumann USA LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.