Z-2929-2026Class II

GM Helix Implant, Endosseous Dental Implant Article No. 109.984

Name: Z-2929-2026 GM Helix Implant, Endosseous Dental Implant Article No. 109.984
Creator: Straumann USA LLC
Published: 2026-07-13
License: https://open.fda.gov/license/

Straumann USA, LLC / initiated 2026-07-13 / Open, Classified / root cause: labeling and UDI

FDA source

Straumann USA LLC began a recall of GM Helix Implant, Endosseous Dental Implant Article No. 109.984 on 2026-07-13. FDA classified it as Class II and gives the reason as "There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the issue could cause bone compression or...". 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-2929-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-13
Posted: 2026-08-10
Recalling firm: Straumann USA, LLC
Product: GM Helix Implant, Endosseous Dental Implant Article No. 109.984
Product code: NHA Abutment, Implant, Dental, Endosseous
Reason for recall: There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the issue could cause bone compression or difficulty during installation in situations where there is sufficient bone volume
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: On July 13, 2026, the firm began notifying customers through a combination of mail, phone, and email. Letters were sent via overnight UPS delivery. Customers were instructed to check their inventory for the affected article/project numbers. If the product is still in inventory, customer should stop use or distribution immediately and quarantine/segregate physically. Product should be returned to Straumann USA, LLC for replacement. If the product has already been implanted, the firm states that implant removal is not required, and no additional patient follow up is required solely due to this recall.
Quantity in commerce: 417 US
Distribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI.
Product codes and lots: UDI-DI 7899878024552 Lot MVXJ9

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2929-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2929-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-19	2026-08-10

Product code NHA

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)