BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within Tyvek tray within cardboard box; one (1) unit per box. Labeled Sterile"
This recall has been terminated (originally issued March 8, 2017).
- Company
- Biomet 3I, Llc
- Recall Initiated
- March 8, 2017
- Terminated
- August 2, 2019
- Recall Number
- Z-1701-2017
- Quantity
- 5
- Firm Location
- Palm Beach Gardens, FL
- Official Source
- View on FDA website ↗
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
Lot / Code Info
LTX610, lot 1199571; UDI: (01)00844868009917(17)210916(10)1199571
Root Cause
Under Investigation by firm
Action Taken
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