Dental implant kits recalled for mislabeled implant dimensions
Straumann USA LLC is recalling certain Neodent Easypack dental implant kits due to mislabeling where packaging does not match the implant dimensions inside. Affected units contain 3.5x8mm implants instead of the labeled 3.5x13mm size.
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 recall of mislabeled surgical implants. While no illnesses or injuries have been reported, the dimensional mismatch presents a clear risk of harm if implants are selected and placed based on the inaccurate labeling.
Plain-English summary
Straumann USA LLC is recalling the Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 (Article Number 138.107) dental implant kits. The carton boxes are mislabeled and contain implants with incorrect dimensions.
The mislabeled units contain dental implants measuring 3.5x8mm, but the carton labeling indicates they are 3.5x13mm implants. This dimensional discrepancy could result in incorrect implant selection or placement during surgical procedures.
The affected implant kits were distributed nationwide with concentration in Florida, Illinois, and Ohio under Lot GNV20 (UDI: 7899878052906). Healthcare providers and surgical facilities that received these kits should verify the actual implant dimensions before use and contact Straumann USA LLC with questions about affected inventory.
The recalled product
- Product
- Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107
- Manufacturer
- Straumann USA LLC
- Affected units
- 1
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 GNV20: UDI:7899878052906
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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