The Recall Desk
HighFDA (Devices)·Z-0197-2022·Announced 2021-11-10

Dental implants recalled for size mismatch with package labeling

Implant Direct is recalling 61 dental implants because the packaged implants are a different size than declared on the labeling. Patients who may have received these implants should contact their healthcare provider.

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: This is a risk-of-harm medical device recall where the implant size does not match the package labeling. No illnesses or injuries have been reported. The discrepancy could affect proper implant fit and integration, but absent reported harm and with no FDA Class I designation, this meets the criteria for High (3) severity.

Plain-English summary

Implant Direct Sybron Manufacturing LLC is recalling the ImplantDirect Legacy 2 Implant (Model REF 834711, 4.7mmD x 11.5mmL with 4.5mmD Platform). A total of 61 implants with lot number 166297 (UDI 10841307101789) are affected by this recall.

The dental implants in the recalled packages are a different size than what is declared on the package labeling. The size discrepancy could affect proper implant fit and integration, potentially impacting long-term patient outcomes.

The affected implants were distributed worldwide, including throughout the United States in Arizona, California, Hawaii, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Montana, Nebraska, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Virginia, Washington, and Wisconsin, as well as Japan.

Patients who believe they may have received one of these implants should contact their dentist or healthcare provider. Healthcare providers can reference lot number 166297 and UDI 10841307101789 when checking patient records.

The recalled product

Product
ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,
Manufacturer
Implant Direct Sybron Manufacturing LLC
Category
Medical Device — Dental Implants
Hazard
  • size-mismatch
  • labeling-error

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 # 166297 / UDI: 10841307101789

Distribution

Distributed nationwide across the United States.

Related recalls

Same category