FDA Medical Device Recalls (openFDA)
Biomet 3i, LLC: BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within Tyvek tray within cardboard box; one (1) unit per box. Labeled Sterile"
- Recall number
- Z-1701-2017
- Recalling firm
- Biomet 3i, 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"
- Status
- Terminated
- Initiated
- 2017-03-08
- Posted
- not on file
- Terminated
- 2019-08-02
- Reason
- 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
- 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 postmarket@zimmerbiomet.com 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 postmarket@zimmerbiomet.com. 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 postmarket@zimmerbiomet.com. 1-800-342-5454
- Quantity
- 5
- Distribution
- Argentina
- Lot, serial or model codes
- LTX610, lot 1199571; UDI: (01)00844868009917(17)210916(10)1199571
- 510(k) numbers
- ["K063286"]
- PMA numbers
- not on file
- Product code
- DZE
- Firm FEI
- 1038806
- Firm city
- Palm Beach Gardens
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28