Z-3173-2026Class II

GM Helix Implant, REF: 109.984

Name: Z-3173-2026 GM Helix Implant, REF: 109.984
Creator: Straumann USA LLC
Published: 2026-08-12
License: https://open.fda.gov/license/

Straumann USA LLC / initiated 2026-08-12 / Open, Classified

FDA source

Recall record

Recall number: Z-3173-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-08-12
Posted: 2026-09-15
Recalling firm: Straumann USA LLC
Product: GM Helix Implant, REF: 109.984;
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
FDA root cause: Under Investigation by firm
Action: On August 12, 2026, Urgent Field Safety Action letters were sent to customers. Actions to be taken: 1. Identify and segregate any units in your stock with carton packaging labeled as Article 109.984 Helix GM Implant, 4.0 x 11.5 mm, L ot VZPF4 2. If the article is still in your inventory, then stop use/ distribution of the product immediately and quarantine / segregate physically. 3. Please return the affected items to the attention of Todd Shevlin at Straumann USA, LLC for replacement as indicated on the Customer Confirmation Form. 4. If the product has already been implanted, implant removal is not required, and no additional patient follow -up is required solely due to this recall 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. If product is not being returned, the completed Customer Confirmation Form can be scanned and emailed to [email protected]
Quantity in commerce: 216
Distribution: 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;
Product codes and lots: REF: 109.984; UDI: (01)7899878024552(11)251122(17)301121(10)VZPF4; Lot: VZPF4;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3173-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3173-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-15

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 2026-09-18. View this recall on fda.gov (opens on fda.gov)