Device Recall Persona Trabecular Metal Tibial Plate / Persona TM Tibia

  • Model / Serial
    All lots and sizes; Sizes C-J Left and Right.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- US, including the states of AK, AL, AZ, CA, CO, FL, IL, IN, KS, MA, MI, MN, MO, NC, NJ, NY, OH, OK, PA, TN, TX, UT, VA, WA, and WI; Foreign:Canada, Australia, New Zealand, Korea, Austria, Belgium, Germany, Italy, Luxembourg, Netherlands, South Africa, Sweden, Switzerland, and United Arab Emirates. DOD/VA: HOSPITAL- VA MAINE HLTCR SYTM (402) VA MROC (402) ATTN: PROSTHETICS DEPT TOGUS ME 04330 207-672-9425 HOSPITAL VA MED CTR (438) 2501 W 22 SIOUX FALLS, SD 57105 605-336-8922 HOSPITAL VA MED CTR (509)1 FREEDOM WAY AUGUSTA , GA 30904 706-721-6892 HOSPITAL VA MED CTR (521) 700 S 19TH ST, BIRMINGHAM, AL 35233 378-962-1599 HOSPITAL VA MED CTR (523) 1400 VFW PARKWAY, WEST ROXBURY, MA 02132 617-862-5977 HOSPITAL VA MED CTR (528) 3495 BAILEY AVENUE BUFFALO, NY 14215 716-898-6922 HOSPITAL VA MED CTR (552) 4100 WEST 3RD STREET BLDG # 330 RECEIVING, DAYTON, OH 45428 937-226-5987 HOSPITAL VA MED CTR (583), 1481 WEST 10TH STREET INDIANAPOLIS, IN 46202 317-267-8765 HOSPITAL VA MED CTR (595) 1700 SOUTH LINCOLN AVENUE, LEBANON, PA 17042 717-272-6621 HOSPITAL VA MED CTR (657) 915 N GRAND BLVD, ST LOUIS, MO 63106 314-652-4100 HOSPITAL VA MED CTR (664) 350 LA JOLLA VILLAGE DR SAN DIEGO, CA 92161 858-552-8585 HOSPITAL VA MED CTR (693) 1111 EAST END BOULEVARD, WILKES BARRE, PA 18711 717-824-3521 HOSPITAL VA SNHCS (654/118) 975 KIRMAN AVENUE RENO NV 89502 702-597-1699
  • Product Description
    Persona Trabecular Metal Tibial Plate / Persona TM Tibia-Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer || For use in either posterior cruciate retaining or sacrificing surgical procedures.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Zimmer, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA