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GM Helix Acqua Implant, Article Number: 140.984 recallZ-1862-2025 · Straumann USA LLC · initiated May 1, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Straumann USA LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-1862-2025
Status
Open, Classified
Initiated by the company
May 1, 2025
Posted by the FDA
May 28, 2025
Recalling firm
Straumann USA LLC
Quantity
300 units (125 US, 175 OUS)
Product code
DZE
FDA submissions
K163194
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.

Product description

GM Helix Acqua Implant, Article Number: 140.984

Code information (models, lots, serial numbers)

Article Number: 140.984; UDI-DI: (01)7899878025290(11)220122(17)260121(10)JPZ21; Lot number: JPZ21;

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 96806).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page