Recall Z-1701-2017— Biomet 3i, LLC
Class II · Terminated
Class II FDA medical device recall by Biomet 3i, LLC, initiated 2017-03-08, terminated 2019-08-02. It names one FDA 510(k) clearance: K063286. Product: BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within Tyvek tray within cardboard box; one (1) unit per box. Labeled Sterile". 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.
- Recalling firm
- Biomet 3i, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-03-08
- Terminated
- 2019-08-02
- Firm location
- Palm Beach Gardens, FL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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"
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.