Food, drugs, devices › Biomet 3i, LLC
Device recall: BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within Tyvek tray within cardboard box; one (1) unit
FDA enforcement event 76809 is a device recall by Biomet 3i, LLC of Palm Beach Gardens, FL, initiated 8 Mar 2017 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 2 Aug 2019. Initiation: voluntary: firm initiated. Biomet 3i, LLC has 24 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Biomet 3i, LLC, Palm Beach Gardens, FL.
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"
Distribution
"Argentina"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1701-2017 | BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within Tyvek tray within cardboard box; one (1) unit per box. Labeled Sterile" | 5 | Class II | Terminated | 5 Apr 2017 |
Context
Other enforcement events for Biomet 3i, LLC
All 24 events for Biomet 3i, LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall 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"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Argentina"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 2 Aug 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.