The Recall Desk
LowFDA (Devices)·Z-1920-2018·Announced 2018-05-30

Implant Direct Legacy 4 Implant Recalled for Mislabeling

Implant Direct Sybron Manufacturing is recalling 18 units of Legacy 4 Implants due to a mislabeled vial cap. The main label was correct, but the cap showed the wrong part number.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is for a minor labeling error on the vial cap where the main label was correct, fitting the rubric for cosmetic defects or documentation issues.

Plain-English summary

Implant Direct Sybron Manufacturing, LLC is recalling 18 units of ImplantDirect Legacy 4 Implants, 5.7mmD x 5.7mmD Platform, Part 885708. The recall is due to a labeling error on the vial cap.

The vial cap was mislabeled with the incorrect part number 855708, although the product description on the cap was correct. The main vial label was correctly labeled. The affected lot is #71729.

Distribution was made to Florida, Georgia, Maryland, Michigan, North Carolina, New York, Oregon, Texas, Utah, and Virginia. There was no foreign, military, or government distribution. Consumers and healthcare providers should check their inventory for this specific part number and lot.

The recalled product

Product
ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile. The incorrect cap label shows part 855708, 5.7mmD Platform, 8mmL.
Affected units
18

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 #71729

Distribution

Distributed in 10 states:

Same manufacturer · Implant Direct Sybron Manufacturing, LLC

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