GM Helix Implant recall

There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.

GM Helix Implant, REF: 109.984;

Quantity: 216

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Company

Straumann USA LLC, Andover, MA

Date

Wednesday, September 23

Severity

Class II
the product could cause temporary or reversible health problems.

Where sold

Nationwide
US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, IL, KS, LA, MA, MI, MO, NC, NJ, NV, NY, OH, OK, OR, PA, SC, TX, VA, WI;

Status

Ongoing

Recall number

Z-3173-2026

Source

U.S. Food and Drug Administration