AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. Product Usage: For use in Total Knee Arthroplasty.
Recall
- Recall Number
- Z-0627-2018
- Event Number
- 79095
- Firm
- Zimmer Biomet, Inc.
- FEI Number
- 1825034
- Product Code
- JWH
- Status
- Terminated
- Root Cause
- Process change control
- Initiated
- August 25, 2017
- Terminated
- August 9, 2018
- Address
- 56 E Bell Dr, Warsaw, IN, 46582-6989
Description
AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. Product Usage: For use in Total Knee Arthroplasty.
The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension.
Consignees were notified via mail on approximately 08/25/2017. Instructions to distributors, sales representatives, and distributor operations managers include to ensure affected team members are aware of the recall, locate and quarantine affected product in inventory, complete and return the Certification of Acknowledgement, return all affected product, and provide any additional hospitals and/or surgeons that received direct shipments. Instructions to risk managers and surgeons include to ensure affected personnel are informed of the recall, quarantine all affected product, return any affected product in inventory, and complete and return the Certificate of Acknowledgment. Questions or concerns can be sent to the Zimmer Biomet customer call center at 1-574-371-3071 between 8:00 am and 5:00 pm EST, Monday through Friday. Or they can be sent via email to [email protected].
US Nationwide Distribution to IN, MO, NY, TX.
28 devices