The Recall Desk
HighFDA (Devices)·Z-0198-2022·Announced 2021-11-10

Dental implant recalled due to size mismatch with labeling

Implant Direct Sybron Manufacturing is recalling 83 dental implants from lot 166300 because the implants differ in size from what is labeled on the packaging. The implants were distributed across multiple US states and Japan.

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 FDA Class II recall involves a product defect where the implant size does not match the labeled specifications. While no injuries or illnesses have been reported, an incorrectly-sized implant poses a risk of improper fit and failure for an implanted medical device, warranting the High severity classification per the rubric criterion for risk-of-harm products without reported injury.

Plain-English summary

Implant Direct Sybron Manufacturing LLC is recalling 83 dental implants, model ImplantDirect Legacy 2 Implant (4.7mm diameter x 13mm length, 4.5mm platform), lot number 166300. The UDI for the affected implants is 10841307101796.

The recalled implants contain a different size than what is declared on the product labeling. This size mismatch creates a risk that the implant may not fit as intended or may not function properly when implanted.

The affected implants were distributed nationwide in the United States (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) and in Japan.

Patients who received implants from this lot should contact their dentist or oral surgeon for evaluation. Healthcare providers should check their inventories for the affected lot number and cease use of implants from this batch.

The recalled product

Product
ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,
Manufacturer
Implant Direct Sybron Manufacturing LLC
Category
Medical Device — Dental Implant
Hazard
  • size-mismatch
  • product-defect

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 # 166300 / UDI: 10841307101796

Distribution

Distributed nationwide across the United States.

Related recalls

Same category