Z-0185-2018Class II

ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 This Legacy implant is a two-piece implant for...

Name: Z-0185-2018 ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 This Legacy implant is a two-piece implant for...
Creator: Implant Direct Sybron Manufacturing, LLC
Published: 2017-10-10
License: https://open.fda.gov/license/

Implant Direct Sybron Manufacturing LLC / initiated 2017-10-10 / Terminated / root cause: manufacturing process

FDA source

Implant Direct Sybron Manufacturing, LLC began a recall of ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 This Legacy implant is a two-piece implant for one-stage or two-stage surgical procedures. These... on 2017-10-10. FDA classified it as Class II and gives the reason as "One reported complaint and discovered that the outer vial was out of round and undersized. Therefore a portion of the opening may not allow inner vial and components to slide freely out of the vial. As a result, the cap...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0185-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-10
Posted: 2017-11-29
Terminated: 2018-09-27
Recalling firm: Implant Direct Sybron Manufacturing LLC
Product: ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 This Legacy implant is a two-piece implant for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: One reported complaint and discovered that the outer vial was out of round and undersized. Therefore a portion of the opening may not allow inner vial and components to slide freely out of the vial. As a result, the cap could possibly not be screwed on properly and the sterilization compromised.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: The firm, Implant Direct Sybron Manufacturing, LLC, sent an "URGENT: Safety Alert/Advisory Notice" letter to its distributors/customers on 10/10/2017. Distributors were instructed as follows: "1. Please review your inventory for the affected product. 2. Please complete and return the Acknowledgement and Recall Return Form within 48 hours. 3. If you are an authorized Implant Direct Sybron Manufacturing 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 fortyeight (48) hours of receipt of this notification in order to provide the customers with replacement product." Enclosed within this notification, you will find a padded return envelope with replacement product. Please return affected product in the padded envelope. If you have any questions contact Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425. Customers were instructed as follows: "1. Please review your inventory for the affected product. 2. Please complete and return the Acknowledgement and Recall Return Form within 48 hours. Please share this information with your staff and retain this notification as part of your documentation. Enclosed within this notification, you will find a padded return envelope with replacement product. Please return affected product in the padded envelope. If you have any questions contact Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425."
Quantity in commerce: 75 units
Distribution: Worldwide distribution: US (nationwide) including Puerto Rico and country of Japan.
Product codes and lots: Lot Number: 79607

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0185-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0185-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-06	2017-11-28

Product code DZE

K090234Class IISpectra System Dental Implants 2008Implant Direct, LLC / cleared 2009-05-15

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)