Z-0018-2020Class II

ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile...

Name: Z-0018-2020 ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile...
Creator: Implant Direct Sybron Manufacturing, LLC
Published: 2018-08-08
License: https://open.fda.gov/license/

Implant Direct Sybron Manufacturing LLC / initiated 2018-08-08 / Terminated / root cause: manufacturing process

FDA source

Implant Direct Sybron Manufacturing, LLC began a recall of ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap... on 2018-08-08. FDA classified it as Class II and gives the reason as "Two units in distribution were found to be mislabeled on the vial cap with the incorrect part number". 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-0018-2020
Classification: Class II
Status: Terminated
Initiated: 2018-08-08
Posted: 2019-10-01
Terminated: 2019-10-07
Recalling firm: Implant Direct Sybron Manufacturing LLC
Product: ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants 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: Two units in distribution were found to be mislabeled on the vial cap with the incorrect part number.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Recall letters dated 8/8/2018 were issued on 8/8/2018 via FedEx overnight mail to the U.S. and Canadian consignees and via email to the UAE consignee.
Quantity in commerce: 22 vials
Distribution: Worldwide distribution - US Nationwide including the states of CO, HI, ID, KS, NC, OH, OR, PA, SC, TN, and UT, and countries of Canada and the United Arab Emirates.
Product codes and lots: Lot number 110350

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0018-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0018-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-09	2019-10-01

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)