Z-0197-2022Class II

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

Name: Z-0197-2022 ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform
Creator: Implant Direct Sybron Manufacturing LLC
Published: 2021-09-23
License: https://open.fda.gov/license/

Implant Direct Sybron Manufacturing LLC / initiated 2021-09-23 / Open, Classified / root cause: packaging

FDA source

Implant Direct Sybron Manufacturing LLC began a recall of ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform on 2021-09-23. FDA classified it as Class II and gives the reason as "Packaged dental implant contains a different size then the size declared on the labeling". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0197-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-09-23
Posted: 2021-11-03
Recalling firm: Implant Direct Sybron Manufacturing LLC
Product: ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: Packaged dental implant contains a different size then the size declared on the labeling.
Root cause tag: packaging
FDA root cause: Packaging change control
Action: 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]
Quantity in commerce: 61 implants
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 codes and lots: lot # 166297 / UDI: 10841307101789

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0197-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0197-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-11-10	2021-11-03
Z-0198-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-11-10	2021-11-03

Product code DZE

K192221Class IILegacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mountsImplant Direct Sybron Manufacturing, LLC / cleared 2020-06-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)