Device Recall PERSONA

  • Model / Serial
    Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots Catalog Number: 42-5279-002-00 thru 42-5279-009-04: 42-5279-002-00 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, CD, 10mm; 42-5279-002-02 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, CD, 12mm; 42-5279-002-04 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, CD, 14mm; 42-5279-004-00 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, EF, 10mm; 42-5279-004-02 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, EF, 12mm; 42-5279-004-04 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, EF, 14mm; 42-5279-006-00 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, GH, 10mm; 42-5279-006-02 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, GH, 12mm; 42-5279-006-04 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, GH, 14mm; 42-5279-008-00 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, J, 10mm; 42-5279-008-02 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, J, 12mm; 42-5279-008-04 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, J, 14mm; 42-5279-003-00 All Lots Persona TASP (Tibial A/S Provisional) Shim, CD, 10mm; 42-5279-003-01 All Lots Persona TASP (Tibial A/S Provisional) Shim, CD, 11mm; 42-5279-003-02 All Lots Persona TASP (Tibial A/S Provisional) Shim, CD, 12mm; 42-5279-003-03 All Lots Persona TASP (Tibial A/S Provisional) Shim, CD, 13mm; 42-5279-003-04 All Lots Persona TASP (Tibial A/S Provisional) Shim, CD, 14mm; 42-5279-005-00 All Lots Persona TASP (Tibial A/S Provisional) Shim, EF, 10mm; 42-5279-005-01 All Lots Persona TASP (Tibial A/S Provisional) Shim, EF, 11mm; 42-5279-005-02 All Lots Persona TASP (Tibial A/S Provisional) Shim, EF, 12mm; 42-5279-005-03 All Lots Persona TASP (Tibial A/S Provisional) Shim, EF, 13mm; 42-5279-005-04 All Lots Persona TASP (Tibial A/S Provisional) Shim, EF, 14mm; 42-5279-007-00 All Lots Persona TASP (Tibial A/S Provisional) Shim, GH, 10mm; 42-5279-007-01 All Lots Persona TASP (Tibial A/S Provisional) Shim, GH, 11mm; 42-5279-007-02 All Lots Persona TASP (Tibial A/S Provisional) Shim, GH, 12mm; 42-5279-007-03 All Lots Persona TASP (Tibial A/S Provisional) Shim, GH, 13mm; 42-5279-007-04 All Lots Persona TASP (Tibial A/S Provisional) Shim, GH, 14mm.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA Nationwide including DC, and PR and the countries of Australia, Austria, Belgium, Canada, Czech Republic, Dominican Republic, France, Germany, India, Iran, Israel, Italy, Japan, Luxembourg, Netherlands, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom.
  • Product Description
    Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots Catalog Number: 42-5279-002-00 thru 42-5279-009-04. || Product Usage: The Persona TASPs are sterilizable instruments Intended for multiple uses. The TASP components are used to aid the surgeon in assessing the thickness of the articular surface required. The TASP construct is utilized while conducting a trial range of motion. The TASP consists of 3 parts: a TASP bottom, a TASP shim, and a TASP top. The shims come in varying thicknesses to allow trialing for specific Articular Surface implant thicknesses.
  • 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

37 devices with a similar name

Learn more about the data here

  • Model / Serial
    Item: 42-5399-023-00 Lots: 62072307 62072565 62085420 62192754
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in the states of MN; NJ; NC; PA; AL; MI; OR; FL; OH; CO; IL and CA, and the countries of Australia, India, UAE, Germany, and Italy.
  • Product Description
    Persona Cemented Tibial Broach Inserter/Extractor. || The Persona Cemented Tibial Broach Inserter/Extractor Handle is a Use sterilizable instrument intended for use In multiple TKA procedures. The Persona Surgical Technique indicates that the Persona Cemented Tibial Broach Inserter/Extractor Handle is intended to broach the proximal tibia in preparation for the full seating of the tibial implant.
  • Manufacturer
  • 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
  • Model / Serial
    Part # 42-5099-088-10; Lots: 56573342; 56574505; 56574999; 56574229; 56574818; 56575000; 56574230; 56574819; 56575020; 56574301; 56574820; 56575021; 56574349; 56574861; 56575072; 56574374; 56574862; 56575105; 56574375; 56574863; 56574504; 56574998;
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US including Domestic: Puerto Rico, AZ, NY. OR, ME, NC, OH, TX, CO, IL, TN, PA, HI, CA, KS, WI, VA, MN, NJ, UT, MA, GA, MI, OK, MS, FL, AL, IN, and Internationally to Germany, India, Dominican Republic, Singapore, Korea, Japan, Austrailia, Canada.
  • Product Description
    Brand Name: Persona¿ Anterior Referencing Sizer with Locking Boom || The Persona Anterior Referencing Sizer is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. The Persona Surgical Technique (97-5026-001-00, Rev. 9) states that the sizer helps ensure that the desired external rotation is attained and provides a size for the femoral component.
  • Manufacturer
  • Model / Serial
    Proximal Tube Item Number 42-5399-001-00, Lots: 2137111, 62156913, 62222598.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • 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.
  • Product Description
    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.
  • Manufacturer
  • Model / Serial
    Distal Rod Item Number 42-5399-002-00 Lots: 62137112, 62156914, 62222599.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • 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.
  • Product Description
    Persona EM Distal Rod, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-002-00, part of the Persona Tibial Resection System.
  • Manufacturer
32 more