The Recall Desk
HighFDA (Devices)·Z-0513-2022·Announced 2022-01-26

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.

What this means for you

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
Category
Medical Device — Surgical Implants / Dental
Hazard
  • mis-labeling
  • implant-dimensional-mismatch

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

Distributed nationwide across the United States.

Related recalls

Same category