Straumann Recalls GM Helix Implants Due to Packaging Dimension Discrepancy
Straumann USA LLC is recalling 216 GM Helix Implants because the packaging identification does not match the actual implant dimensions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling/packaging discrepancy without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Straumann USA LLC is voluntarily recalling 216 units of GM Helix Implants, Reference 109.984, Lot VZPF4. The recall was initiated because there is a discrepancy between the product identification on the packaging and the actual dimensions of the implant contained inside.
The affected products were distributed nationwide in the United States, specifically in the states of Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Kansas, Louisiana, Massachusetts, Michigan, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Virginia, and Wisconsin.
Consumers and healthcare providers should stop using the affected implants and contact Straumann USA LLC for further instructions or a replacement. The recall is classified as Class II by the FDA.
The recalled product
- Product
- GM Helix Implant, REF: 109.984;
- Manufacturer
- Straumann USA LLC
- Category
- Medical Device — Dental Implants
- Affected units
- 216
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- REF: 109.984
- UDI: (01)7899878024552(11)251122(17)301121(10)VZPF4
- Lot: VZPF4
Distribution
Related recalls
Same manufacturer · Straumann USA LLC
See all →- ModerateStraumann Recalls GM Helix Dental Implants Due to Labeling Mismatch
FDA (Devices) · 2026-08-19
- ModerateStraumann BLT Dental Implant Recall Due to Incorrect Length Labeling
FDA (Devices) · 2026-08-19
- HighStraumann n!ce Zr HT Dental Implant Abutments Recalled for Incorrect Screw Seat
FDA (Devices) · 2026-05-06
- HighStraumann n!ce PMMA Dental Implant Abutments Recalled for Screw Seat Defect
FDA (Devices) · 2026-05-06
- HighStraumann custom abutments made from wrong bar material after mix-up
FDA (Devices) · 2026-04-01
Same hazard · mis labeling
See all →- High
- HighBetterballen Foods Frozen Meat and Poultry Products Alerted for Undeclared Allergens
USDA FSIS · 2026-11-06
- LowMeitheal Pharmaceuticals Recalls Vecuronium Bromide Injection for Labeling Defect
FDA (Drugs) · 2026-11-04
- LowValuHealth Acetaminophen Recalled for Incorrect Bottle Label
FDA (Drugs) · 2026-11-04
- SevereRiad's Oliva to Go Hummus Recalled for Undeclared Sesame
FDA (Food) · 2026-11-04
Similar recalls
- ModerateStraumann Recalls GM Helix Dental Implants Due to Labeling Mismatch
FDA (Devices) · 2026-08-19
- HighGM Helix Acqua Implant dental implant size misidentification recall
FDA (Devices) · 2025-06-04
- ModerateGM Helix Acqua Implant labeled 11.5 mm may contain 13 mm
FDA (Devices) · 2025-06-04
- HighDental Implant Mislabeling: Neodent Easypack Helix GM Acqua Dimension Error
FDA (Devices) · 2022-01-26
- HighDental implant kits recalled for mislabeled implant dimensions
FDA (Devices) · 2022-01-26
- HighDental implants recalled for size mismatch with package labeling
FDA (Devices) · 2021-11-10