Z-0089-2019Class II

Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant...

Name: Z-0089-2019 Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant...
Creator: Implant Direct Sybron Manufacturing, LLC
Published: 2018-05-29
License: https://open.fda.gov/license/

Implant Direct Sybron Manufacturing LLC / initiated 2018-05-29 / Terminated / root cause: manufacturing process

FDA source

Implant Direct Sybron Manufacturing, LLC began a recall of Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant component, used temporarily during impressions for the... on 2018-05-29. FDA classified it as Class II and gives the reason as "Cap may be mislabeled with incorrect part number, although the correct part number is on the main vial label". 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-0089-2019
Classification: Class II
Status: Terminated
Initiated: 2018-05-29
Posted: 2018-10-09
Terminated: 2020-07-29
Recalling firm: Implant Direct Sybron Manufacturing LLC
Product: Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant component, used temporarily during impressions for the prosthetic procedure.
Product code: NDP Accessories, Implant, Dental, Endosseous
Reason for recall: Cap may be mislabeled with incorrect part number, although the correct part number is on the main vial label.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On May 29, 2018, Implant Direct Sybron Manufacturing LLC issued URGENT MEDICAL DEVICE RECALL notices to their customers via FedEx overnight mail. Customers were instruction to take the following actions: 1. Review your inventory for the affected product. 2. Complete and return the Acknowledgement Form within 48 hours for the product listed; Quarantine and return impacted product. 3. Authorized Implant Direct Sybron Manufacturing LLC distributors, should identify those customers that may have been shipped the affected product lot and contact these customers to inform them of this issue within48 hours of receipt of the notification. Customers with questions may 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.
Quantity in commerce: 217 units
Distribution: Worldwide distribution. US nationwide, Canada, Germany, Great Britain, Kuwait, Lithuania, Monaco, Netherlands, and Slovakia.
Product codes and lots: Part number 8735-05, Lot number 90212

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0089-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0089-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-17	2018-10-09

Product code NDP

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)