Straumann Recalls GM Helix Dental Implants Due to Labeling Mismatch
Straumann USA LLC is recalling 417 GM Helix dental implants because the implant inside the packaging may not match the outer carton label, potentially causing installation issues.
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, but the source text describes a labeling mismatch that could cause installation difficulty or bone compression without reporting any actual injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Straumann USA LLC is recalling 417 units of the GM Helix Implant, Endosseous Dental Implant (Article No. 109.984). The recall is due to a potential mismatch between the implant contained inside the packaging and the information described on the outer carton label.
If an incorrect implant is installed, the issue could cause bone compression or difficulty during installation in situations where there is sufficient bone volume. The affected products are identified by UDI-DI 7899878024552 and Lot MVXJ9.
The recalled products were distributed nationwide in the United States, 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, and WI. Consumers and healthcare providers should check their inventory for this specific lot number and contact Straumann USA LLC for further instructions.
The recalled product
- Product
- GM Helix Implant, Endosseous Dental Implant Article No. 109.984
- Manufacturer
- Straumann USA LLC
- Category
- Medical Device — Dental Implant
- Affected units
- 417
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 (1)
- UDI-DI 7899878024552 Lot MVXJ9
Distribution
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