Z-1041-2020Class II

Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213

Name: Z-1041-2020 Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213
Creator: Implant Direct Sybron Manufacturing LLC
Published: 2019-10-07
License: https://open.fda.gov/license/

Implant Direct Sybron Manufacturing LLC / initiated 2019-10-07 / Terminated / root cause: packaging

FDA source

Implant Direct Sybron Manufacturing LLC began a recall of Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213 on 2019-10-07. FDA classified it as Class II and gives the reason as "Some dental implant packages contain incorrect implants, which could lead to surgery rescheduling". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1041-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-07
Posted: 2020-02-04
Terminated: 2021-04-28
Recalling firm: Implant Direct Sybron Manufacturing LLC
Product: Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: Some dental implant packages contain incorrect implants, which could lead to surgery rescheduling.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: On 10/07/19, Urgent Medical Device Recall notices were mailed via overnight mail to US customers who were asked to return affected product and to complete and return the acknowledgement form. Consignees in foreign countries were sent Recall notices via overnight mail and/or email on 10/11/2019. Distributors were asked to identify customers that may have received affected product and to inform them of this issue. US Customers with additional questions were encouraged to call Customer Care, Monday through Friday, between 5am-5pm PST, at 1-888-649-6425.
Quantity in commerce: 72
Distribution: U.S. Nationwide distribution in the states of: KS, LA, OH, RI, CA, NJ, MA, FL, UT, ID, MO, WY, WI, PA, WA. O.U.S. (Foreign): DE, IT, HU, JP
Product codes and lots: Lot: 83327

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1041-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1041-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05

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)