Z-0010-2020Class II

ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The...

Name: Z-0010-2020 ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The...
Creator: Implant Direct Sybron Manufacturing, LLC
Published: 2018-08-07
License: https://open.fda.gov/license/

Implant Direct Sybron Manufacturing LLC / initiated 2018-08-07 / Terminated / root cause: manufacturing process

FDA source

Implant Direct Sybron Manufacturing, LLC began a recall of ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron... on 2018-08-07. FDA classified it as Class II and gives the reason as "The incorrect device was packaged in the vial". 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-0010-2020
Classification: Class II
Status: Terminated
Initiated: 2018-08-07
Posted: 2019-10-01
Recalling firm: Implant Direct Sybron Manufacturing LLC
Product: ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: The incorrect device was packaged in the vial.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The recalling firm issued letters dated 8/7/2018 via FedEx or email on 8/7/2018 informing the consignee of the issue and requesting they review their inventory for the affected product and quarantine it until it is returned.
Quantity in commerce: 158 devices
Distribution: Distribution was made to AL, AZ, CA, CO, CT, FL, GA, ID, IL KY, MA, MD, NM, NV, NY, PA, and TX. There was no government/military distribution. Foreign distribution was made to Germany, Great Britain, Italy, Spain, Trinidad & Tobago, and UAE.
Product codes and lots: Lot 108191, UDI (01)10841307108313(17)230118(10)108191

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0010-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0010-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-09	2019-10-01

Product code DZE

K061319Class IISpectra SystemImplant Direct, LLC / cleared 2006-09-29

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)