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Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform… recallZ-1041-2020 · Implant Direct Sybron Manufacturing LLC · initiated Oct 7, 2019

Class II Terminated All recalls posted in February 2020

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Implant Direct Sybron Manufacturing LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Some dental implant packages contain incorrect implants, which could lead to surgery rescheduling.

FDA root cause category: Packaging process control

What the company is doing

On 10/07/19, Urgent Medical Device Recall notices were mailed via overnight mail to US customers who were asked to return affected product and to complete and return the acknowledgement form. Consignees in foreign countries were sent Recall notices via overnight mail and/or email on 10/11/2019. Distributors were asked to identify customers that may have received affected product and to inform them of this issue. US Customers with additional questions were encouraged to call Customer Care, Monday through Friday, between 5am-5pm PST, at 1-888-649-6425.

Recall details

Recall number
Z-1041-2020
Recall class
Class II
Status
Terminated
Initiated by the company
Oct 7, 2019
Posted by the FDA
Feb 4, 2020
Recalling firm
Implant Direct Sybron Manufacturing LLC
Quantity
72
Product code
DZE
FDA submissions
K090234
Distribution
U.S. Nationwide distribution in the states of: KS, LA, OH, RI, CA, NJ, MA, FL, UT, ID, MO, WY, WI, PA, WA. O.U.S. (Foreign): DE, IT, HU, JP

Product description

Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213

Code information (models, lots, serial numbers)

Lot: 83327

Other devices under the same FDA submission

123 devices cleared under K090234 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page