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Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA… recallZ-0364-2020 · Implant Direct Sybron Manufacturing, LLC · initiated Aug 9, 2019

Class II Terminated All recalls posted in November 2019

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

A QA inspection confirmed that a Healing Collar (Part number 8735-15) was packaged instead of the Implant ordered.

FDA root cause category: Packaging

What the company is doing

Implant Direct Sybron Manufacturing LLC mailed out an urgent medical device recall notice on 8/9/2019 to its customers via FedEx overnight priority instructing them to take the following actions: 1. Please review your inventory for the affected product. If located, please quarantine the affected product and return the product to us according to the instructions on the attached form. 2. Please complete and return the Acknowledgement Form within fortyeight (48) hours, whether you have affected product or not. 3. If you are an authorized Implant Direct Sybron Manufacturing LLC distributor, we request that you identify those customers that may have been shipped the affected product and contact these customers to inform them of this issue within fortyeight (48) hours of receipt. 4.If you have any of the affected product listed above, please return the product and we will send you a replacement part. 5.If you have any questions, please contact Implant Direct Sybron Manufacturing LLC Customer Care at 888-649-6425. Customer Care is available Monday through Friday, between the hours of 5am-5pm PST. 6.If you or your patients have experienced any issues as a result of the affected products noted in this communication, you may voluntarily report the incident to the FDA through the MEDWATCH reporting system at the following: http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053074.htm

Recall details

Recall number
Z-0364-2020
Recall class
Class II
Status
Terminated
Initiated by the company
Aug 9, 2019
Posted by the FDA
Nov 12, 2019
Recalling firm
Implant Direct Sybron Manufacturing, LLC
Quantity
23 implants
Product code
DZE
FDA submissions
K090234
Distribution
U.S.: IN, VA, MD, TX, WA OUS: Japan

Product description

Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants

Code information (models, lots, serial numbers)

Lot #135128 Exp: 3/12/20

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