Z-1917-2018Class II

ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile...

Name: Z-1917-2018 ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile...
Creator: Implant Direct Sybron Manufacturing, LLC
Published: 2018-03-14
License: https://open.fda.gov/license/

Implant Direct Sybron Manufacturing LLC / initiated 2018-03-14 / Terminated / root cause: labeling and UDI

FDA source

Implant Direct Sybron Manufacturing, LLC began a recall of ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile. Incorrect label on the cap says 4.3mmD Platform... on 2018-03-14. FDA classified it as Class II and gives the reason as "The cap on the vial might be labeled with the incorrect part number but the main vial label is correct". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1917-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-14
Posted: 2018-05-23
Terminated: 2018-06-04
Recalling firm: Implant Direct Sybron Manufacturing LLC
Product: ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile. Incorrect label on the cap says 4.3mmD Platform 604313U 13mmL. Product Usage: Usage: 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 cap on the vial might be labeled with the incorrect part number but the main vial label is correct.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: The recall letter dated 3/16/2018 was first issued via email to one of the foreign consignees on 3/14/2018. The U.S. and other foreign consignees were mailed letters on 3/16/2018 via FedEx overnight mail. the letter identified the affected product, problem and actions to be taken.
Quantity in commerce: 298 implants
Distribution: Worldwide Distribution - US Nationwide in the state of AZ, CA, CO, FL, ID, IL, KY, NC, NE, NY, OK, OR, TN, TX, UT, VA, WA, and WI. Foreign distribution was made to Canada, Japan, United Kingdom, France, Switzerland, Netherlands, and Germany.
Product codes and lots: Lot #68960

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1917-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1917-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-30	2018-05-23

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