Z-1701-2017Class II

BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within Tyvek tray within cardboard box...

Name: Z-1701-2017 BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within Tyvek tray within cardboard box...
Creator: Biomet 3i, LLC
Published: 2017-03-08
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2017-03-08 / Terminated / root cause: labeling and UDI

FDA source

Biomet 3i, LLC began a recall of BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within Tyvek tray within cardboard box; one (1) unit per box. Labeled Sterile" on 2017-03-08. FDA classified it as Class II and gives the reason as "A single lot of product that potentially has a single part within the lot that does not match the product on the label due to a commingle at the firm supplier". 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-1701-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-08
Posted: 2017-03-29
Terminated: 2019-08-02
Recalling firm: ZimVie US Corp LLC
Product: BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within Tyvek tray within cardboard box; one (1) unit per box. Labeled Sterile"
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: A single lot of product that potentially has a single part within the lot that does not match the product on the label due to a commingle at the firm supplier
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: On March 13 Zimmer Biomet contacted their international consignee and asked them to: 1. Review this notification and ensure affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1 Inventory Return Certification Form. a. Return a digital copy to [email protected] within three (3) days. 4. Immediately return all affected product from your distributorship within your territory along with a completed Attachment 1 Inventory Return Certification Form to Biomet 3i. a. For each return, send a copy of Attachment 1 to [email protected]. b. Include a hardcopy of Attachment 1 with your shipment for immediate processing. c. Mark the outside of the returns box(es) clearly with RECALL. 5. Retain a copy of your recall acknowledgement and product return forms for your records in the event of a compliance audit of your facility. If after reviewing this notice you have further questions or concerns please contact us by email at [email protected]. 1-800-342-5454
Quantity in commerce: 5
Distribution: Argentina
Product codes and lots: LTX610, lot 1199571; UDI: (01)00844868009917(17)210916(10)1199571

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1701-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1701-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-05	2017-03-29

Product code DZE

K063286Class IIOsseotite; Osseotite Nt; Xp; Tg OsseotiteImplant Innovations, Inc. / cleared 2007-04-24

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)