—#154241

Product

BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within Tyvek tray within cardboard box; one (1) unit per box. Labeled Sterile"

FDA product code: DZE — Implant, Endosseous, Root-Form
Device class: Class 2
Medical specialty: Dental
510(k) numbers: K063286
Affected lot / code info: LTX610, lot 1199571; UDI: (01)00844868009917(17)210916(10)1199571

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm: Biomet 3i, LLC
Address: 4555 Riverside Dr, Palm Beach Gardens, Florida 33410-4200

Distribution

Distribution pattern: Argentina

Timeline

Recall initiated: 2017-03-08
Terminated: 2019-08-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #154241. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.