LTX recallZ-1701-2017 · Biomet 3i, LLC · initiated Mar 8, 2017
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Biomet 3i, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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
FDA root cause category: Under Investigation by firm
What the company is doing
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
Recall details
- Recall number
- Z-1701-2017
- Status
- Terminated
- Initiated by the company
- Mar 8, 2017
- Recalling firm
- Biomet 3i, LLC
- Quantity
- 5
- Product code
- DZE
- FDA submissions
- K063286
- Distribution
- Argentina
Product description
BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within Tyvek tray within cardboard box; one (1) unit per box. Labeled Sterile"
Code information (models, lots, serial numbers)
LTX610, lot 1199571; UDI: (01)00844868009917(17)210916(10)1199571
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- LTX LTX610ZimVie US Corp LLC · IMPLANT, ENDOSSEOUS, ROOT-FORM1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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