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.
What this means for you
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 →- Severe
- HighMercer's Ice Cream Sandwiches Recalled for Undeclared Peanuts
FDA (Food) · 2026-09-23
- SevereNova Biomedical StatStrip Glucose Hospital Meter System Recalled for Software Defect
FDA (Devices) · 2026-09-23
- HighBest Friends Bakery Recalls Pumpkin Spice No Bake Cookies for Allergen Mislabeling
FDA (Food) · 2026-09-23
- ModerateElegant Foods Carrot Cake Recalled for Unlabeled Food Dyes
FDA (Food) · 2026-09-23
Similar recalls
- HighDental implant kits recalled for mislabeled implant dimensions
FDA (Devices) · 2022-01-26
- ModerateStraumann BLT Dental Implant Recall Due to Incorrect Length Labeling
FDA (Devices) · 2026-08-19
- ModerateStraumann Dental Implant Drill Set Recalled for Incorrect Drill
FDA (Devices) · 2015-01-21
- ModerateSouthern Implants Recalls Dental Implants Due to Labeling Mismatch
FDA (Devices) · 2015-03-18
- LowStraumann WB XL Anatomic Healing Abutment XC Dental Implants
FDA (Devices) · 2025-04-30
- HighZimmer Biomet Recalls Mismatched Hip Implant Packages Due to Sizing Error
FDA (Devices) · 2018-04-04