Z-1863-2025Class II

GM Helix Acqua Implant, Article Number: 140.985

Name: Z-1863-2025 GM Helix Acqua Implant, Article Number: 140.985
Creator: Straumann USA LLC
Published: 2025-05-01
License: https://open.fda.gov/license/

Straumann USA, LLC / initiated 2025-05-01 / Open, Classified / root cause: labeling and UDI

FDA source

Straumann USA LLC began a recall of GM Helix Acqua Implant, Article Number: 140.985 on 2025-05-01. FDA classified it as Class II and gives the reason as "It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1863-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-01
Posted: 2025-05-28
Recalling firm: Straumann USA, LLC
Product: GM Helix Acqua Implant, Article Number: 140.985
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 207 units (54 US, 153 OUS)
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 codes and lots: Article Number: 140.985; UDI-DI: (01)7899878024569(11)220125(17)270124(10)JPZ75; Lot number: JPZ75;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1863-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1862-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-04	2025-05-28
Z-1863-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-04	2025-05-28

Product code DZE

K163194Class IINeodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A. / cleared 2017-07-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)