Recalls / —

—#213703

Product

GM Helix Acqua Implant, Article Number: 140.985

FDA product code

DZE — Implant, Endosseous, Root-Form

Device class

Class 2

Medical specialty

Dental

510(k) numbers

K163194

Affected lot / code info

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

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

On May 1, 2025 URGENT FIELD SAFETY ACTION letters were sent to customers. Action to be taken: 1. If article 140.984 Lot JPZ21 or 109.985 Lot JPZ75 are still in your inventory, then stop use/distribution of the product immediately and quarantine/segregate physically. 2. If the product was used and no complications or problems were identified, of the patient did not present symptoms there is no need for any additional action with the patient. 3. If article 140.984 Lot JPZ21 or 109.985 Lot JPZ75 are still in your inventory, return it for a credit or replacement as indicated on the Customer Confirmation Form. 4. In the product is not found in your stock, indicate this on the enclosed Customer Confirmation Form. 5 In all cases, complete and return the enclosed Customer Confirmation Form with the affected product using the return UPS label provided to: Straumann USA, LLC; 60 Minuteman Road, Andover, MA 01810. Transmission of the Field Safety Notice: This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. The FDA has been informed about this Field Safety Corrective Action. We apologize for any inconvenience that this may cause.

Recalling firm

Firm

Straumann USA LLC

Address

60 Minuteman Rd, Andover, Massachusetts 01810-1008

Distribution

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.

Timeline

Recall initiated

2025-05-01

Posted by FDA

2025-05-28

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #213703. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.