Z-2551-2018Class II

ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in...

Name: Z-2551-2018 ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in...
Creator: Implant Direct Sybron Manufacturing, LLC
Published: 2017-03-03
License: https://open.fda.gov/license/

Implant Direct Sybron Manufacturing LLC / initiated 2017-03-03 / Terminated / root cause: manufacturing process

FDA source

Implant Direct Sybron Manufacturing, LLC began a recall of ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and... on 2017-03-03. FDA classified it as Class II and gives the reason as "The main vial label lists the incorrect part number, but the cap label is correct". 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-2551-2018
Classification: Class II
Status: Terminated
Initiated: 2017-03-03
Posted: 2018-07-26
Terminated: 2018-08-06
Recalling firm: Implant Direct Sybron Manufacturing LLC
Product: ImplantDirect, Dental implants 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: The main vial label lists the incorrect part number, but the cap label is correct.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Recall notifications dated 2/13/2017 were issued to U.S. consignees via UPS overnight on 3/3/2017. Foreign consignees received letters on 3/13/2017 and 3/14/2017.
Quantity in commerce: 124 units
Distribution: Distribution was made to AZ, CA, CO, CT, FL, ID, IL, NC, NJ, NV, NY, PA, TX, UT, VA, and WA. There was no government/military distribution. Foreign distribution was made to Switzerland, Germany, Lithuania, and Spain.
Product codes and lots: Lot #87837

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2551-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2551-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-01	2018-07-26

Product code DZE

K130572Class IIInteractive/ Swishplus2 Implant SystemImplant Direct Sybron Manufacturing, LLC / cleared 2013-12-24

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)