Z-1920-2018Class II

ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile. The incorrect cap label...

Name: Z-1920-2018 ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile. The incorrect cap label...
Creator: Implant Direct Sybron Manufacturing, LLC
Published: 2016-11-15
License: https://open.fda.gov/license/

Implant Direct Sybron Manufacturing LLC / initiated 2016-11-15 / Terminated / root cause: labeling and UDI

FDA source

Implant Direct Sybron Manufacturing, LLC began a recall of ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile. The incorrect cap label shows part 855708, 5.7mmD Platform, 8mmL on 2016-11-15. FDA classified it as Class II and gives the reason as "The vial cap was mislabeled with the incorrect part number of 855708 but the product description on the cap was correct. The main vial label was correctly labeled". 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-1920-2018
Classification: Class II
Status: Terminated
Initiated: 2016-11-15
Posted: 2018-05-23
Terminated: 2018-06-04
Recalling firm: Implant Direct Sybron Manufacturing LLC
Product: ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile. The incorrect cap label shows part 855708, 5.7mmD Platform, 8mmL.
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: The vial cap was mislabeled with the incorrect part number of 855708 but the product description on the cap was correct. The main vial label was correctly labeled.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Letters dated 11/14/2016 were issued via FedEx overnight on 11/15/2016.
Quantity in commerce: 18 units
Distribution: Distribution was made to FL, GA, MD, MI, NC, NY, OR, TX, UT and VA. There was no foreign/military/government distribution.
Product codes and lots: Lot #71729

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1920-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1920-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-30	2018-05-23

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