Skip to content

Legacy2 Implant recallZ-0197-2022 · Implant Direct Sybron Manufacturing LLC · initiated Sep 23, 2021

Open, Classified

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

Packaged dental implant contains a different size then the size declared on the labeling.

FDA root cause category: Packaging change control

What the company is doing

On October 11, 2021, Implant Direct issued an "Urgent: Medical Device Recall" Notice via. Mail . In addition to informing consignees about the recall, the firm ask consignees to take the following actions: 1. Please immediately examine, identify, and quarantine the affected product subject to recall (Table-1). 2. If located, immediately return the affected product with the pre-paid shipping label included with the notification letter to us according to the instructions on the attached form. Upon receipt of the returned product a credit will be issued accordingly. 3. Please complete, scan, and email the Acknowledgement Form within forty eight (48) hours of receipt of this notification, whether you have affected product or not, to [email protected] 4. 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 lot and contact these customers to inform them of this issue within forty eight (48) hours of receipt of this notification. 5. If you have any questions, contact Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425. 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 Implant Direct Sybron Manufacturing sincerely apologizes for the inconvenience this situation may cause. 6. For Questions Contact: Customer Service and Technical Support team Monday through Friday, 8:00 AM to 4:30 PM, Pacific Time Zone Tel: 888-649-6425 Email: [email protected]

Recall details

Recall number
Z-0197-2022
Status
Open, Classified
Initiated by the company
Sep 23, 2021
Recalling firm
Implant Direct Sybron Manufacturing LLC
Quantity
61 implants
Product code
DZE
FDA submissions
K192221
Distribution
Worldwide distribution - US Nationwide distribution in the states of AZ, CA, HI, IL, KS, LA, MA, MD, MI, MO, MT, NE, NJ, NY, OH, OR, PA, RI, SC, TX, UT, VA, WA, WI and the country of Japan.

Product description

ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,

Code information (models, lots, serial numbers)

lot # 166297 / UDI: 10841307101789

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

196 devices cleared under K192221 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 88859).

Sources and updates

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