Dental Implant Mislabeling: Neodent Easypack Helix GM Acqua Dimension Error
Straumann USA LLC recalls Neodent Easypack Helix GM Acqua dental implants due to mislabeling. Implants have incorrect dimensions compared to carton labels, which could affect surgical planning and placement.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II mislabeling on a dental implant medical device where dimension errors represent a risk-of-harm situation that could affect surgical placement and implant function. No illnesses or injuries have been reported, but the hazard is significant.
Plain-English summary
Straumann USA LLC is recalling Neodent Easypack Helix GM Acqua dental implants (Item 138.089 and Item 138.107, lot GNV17) distributed nationwide in Florida, Illinois, and Ohio due to mislabeling. The carton boxes contain implants with dimensions that do not match the stated specifications.
Specifically, the carton box for Item 138.089 (Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5) contains an implant with dimensions of 3.5x13mm rather than the labeled size. The carton box for Item 138.107 (Easypack Helix GM Acqua) contains a 3.5x8mm implant instead of the labeled 3.5x13mm implant. These dimension mismatches could affect surgical planning and implant fit.
The recall includes 7 pieces from lot GNV17. Healthcare providers and patients with these devices should contact Straumann USA LLC immediately to verify actual implant dimensions against carton labeling.
The recalled product
- Product
- Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089
- Manufacturer
- Straumann USA LLC
- Category
- Medical Device — Dental Implant
- Affected units
- 7
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)
- Lot GNV17 UDI: 7899878052722
Distribution
Part of a larger recall action
This product is one of 2 recalled by Straumann USA LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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