Recall Z-0410-2016 ยท LXH Orthopedic Manual Surgical Instrument
Zimmer, Inc.
Persona EM Proximal Tube, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-001-00, part of the Persona Tibial Resection System.
| Date | Dec 10, 2015 (initiated Nov 24, 2015) |
| Status | Terminated |
| Reason | Complaints that the ratchet teeth of the tube are not latching onto the rod. |
| Root cause | Under Investigation by firm |
| Action | Zimmer Biomet initiated a voluntary recall of the Persona EM Proximal Tube and Persona EM Distal Rod due to complaints that the ratchet teeth of the tube are not latching onto the rod via certified mail on 11/24/2015. The firm requests customers quarantine recalled devices, return the customer response forms, and assist in returning the devices to the Zimmer Biomet sales reps. Customers with questions may contact 1-800-348-2759 between 8:00 am and 8:00 pm EST. |
| Quantity | 156 |
| Distribution | Distributed in the states of AZ, CA, ID, IL, IN, KS, MA, MI, MN, MO, NC, NJ, NY, OH, PA, TN, TX, VA, and WA, and the country of Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.