Device Recall Zimmer

  • Model / Serial
    lot no.: 61902234 61930449 62238240 61781914 61818112 61873640 61873641 61921821 61930453 62142331 62171289 61656184 61656185 61663560 61818114 61818116 61818118 61873642 61930459 61969224 61969225 62118686 62238244 62250669 62279154 62279156 61640868 61781919 61781920 61866144 61866145 61969228 62122251 62142308 62171295 62255624 62279159 61663622 61781922 61781927 61831643 61862302 61930474 62142311 62232636 62238251 62283223 62283223N 61663623 61781928 61866147 62092290 62155425 62031720
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution
  • Product Description
    Product 14 consists of all product under product code HSB || , and same usage: || Item no: || 225600230 ASIA ONE-PIECE LAG SCREW || 225600232 ASIA ONE-PIECE LAG SCREW || 225600235 ASIA ONE-PIECE LAG SCREW || 225600237 ASIA ONE-PIECE LAG SCREW || 225600240 ASIA ONE-PIECE LAG SCREW || 225600242 ASIA ONE-PIECE LAG SCREW || 225600245 ASIA ONE-PIECE LAG SCREW || 225600227 ASIA ONE-PIECE LAG SCREW 70MM || Product Usage: || An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Zimmer Manufacturing B.V., Turpeaux Industrial Park Rd 1 km 123.4, Mercedita PR 00715
  • 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

263 devices with a similar name

Learn more about the data here

  • Model / Serial
    Item No. 42-5299-001-00 Affected Lots: 56572679; 56573170; 56574318; 56575056; 56572918; 56573378; 56574538; 56575057; 56572975; 56573379; 56574540; 56575058; 56572978; 56574123; 56574618; 56575059; 56572981; 56574124; 56574619; 56575060; 56572982; 56574223; 56574620; 56575061; 56573071; 56574291; 56574629; 56575062; 56573115; 56574292; 56574630; 56575065; 56573116; 56574316; 56574631; 56575080; 56573154; 56574317; 56575018
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: US nationwide, including Puerto Rico, South Korea, Singapore, Dominican Republic, Canada, Japan, and Germany.
  • Product Description
    Zimmer PERSONA Tibial Articular Surface Inserter; Item # 42-5299-001-00. Manual surgical instrument for knee arthroplasty (orthopedic).
  • Manufacturer
  • Model / Serial
    Item numbers: 01.01012.384; 01.01012.385; 01.01012.386; 01.01012.387; 01.01012.388; 01.01012.444; 01.01012.445; 01.01012.446; 01.01012.447; 01.01012.448   Lot #'s: 2551762, 2542690, 2542691, 2543993, 2544892, 2544893, 2551930, 2551931, 2557054, 2558475, 2559787, 2563363, 2564657, 2568082, 2539887, 2540911, 2544894, 2544895, 2545830, 2545831, 2545832, 2545833, 2547043, 2547807, 2548952, 2551330, 2551860, 2551861, 2554798, 2554799, 2554800, 2558476, 2558477, 2559788, 2561617, 2562662, 2563364, 2563385, 2565407, 2566564, 2567294, 2542692, 2542693, 2544896, 2547044, 2548953, 2551932, 2553210, 2556029, 2559603, 2563386, 2539888, 2540926, 2548954, 2553419, 61487633, 61487634, 61636015, 61495961, 61495962, 61495963, 61562431, 61577697, 61608436, 61562432, 61577709, 61487635, 61562448
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Domestic: AK, AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MS, MA, MD, ME, MI, MN, MO, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY International: Canada, Japan
  • Product Description
    CoCr Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femur in total hip arthroplasty.
  • Manufacturer
  • Model / Serial
    Item numbers: 19.32.05; 19.32.06; 19.32.08;  Lot #'s: 2560585, 2553420, 2556039, 2560586, 2563398
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Domestic: AK, AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MS, MA, MD, ME, MI, MN, MO, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY International: Canada, Japan
  • Product Description
    Metasul Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femur in total hip arthroplasty.
  • Manufacturer
  • Model / Serial
    Item numbers: 00-8775-028-01; 00-8775-028-02; 00-8775-028-03;  00-8775-032-01; 00-8775-032-02; 00-8775-032-03;  00-8775-032-04; 00-8775-036-01; 00-8775-036-02; 00-8775-036-03; 00-8775-036-04; 00-8775-040-01; 00-8775-040-02; 00-8775-040-03; 00-8775-040-04.  Lot #'s:  2524205, 2527529, 2531817, 2543976, 2547030, 2522713, 2535758, 2541605, 2544263, 2538145, 2541613, 2524241, 2524242, 2535756, 2535757, 2538147, 2538184, 2543978, 2543979, 2549572, 2553888, 2557023, 2559372, 2524199, 2524200, 2527535, 2527536, 2527537, 2532038, 2535759, 2535765, 2535766, 2538148, 2538149, 2538152, 2538186, 2545261, 2546980, 2548230, 2551239, 2554875, 2557033, 2524204, 2527538, 2527539, 2538153, 2538189, 2544167, 2551250, 2556148, 2557156, 2535768, 2538190, 2541618, 2544169, 2552353, 2524244, 2524260, 2524261, 2527546, 2527547, 2531818, 2535769, 2535770, 2538165, 2538167, 2538168, 2541619, 2541620, 2544176, 2544177, 2547032, 2552354, 2552365, 2522849, 2524201, 2524202, 2524203, 2527548, 2527549, 2527590, 2531774, 2531815, 2531816, 2538169, 2538170, 2538171, 2538173, 2538175, 2538176, 2541852, 2541853, 2544189, 2544190, 2544191, 2548154, 2552367, 2552368, 2554887, 2554888, 2556180, 2557159, 2557170, 2524262, 2524263, 2527592, 2527593, 2531819, 2535772, 2538177, 2538178, 2538180, 2541866, 2544196, 2545262, 2548170, 2552369, 2556181, 2538191, 2541868, 2524271, 2527594, 2538194, 2538195, 2541869, 2541910, 2541911, 2544198, 2557173, 2568103, 2568982, 2582562, 2583925, 2590223, 2591046, 2591047, 2596627, 2597821, 2600144, 2602748, 2615192, 2617666, 2618635, 2621751, 2623054, 2632524, 2633562, 2635942, 2638898, 2641867, 2642795, 2645303, 2647759, 2651994, 2531222, 2538196, 2538197, 2541912, 2541913, 2544253, 2545245, 2558285, 2566263, 2566672, 2568104, 2570197, 2576875, 2576876, 2583926, 2591048, 2591049, 2596628, 2596954, 2596960, 2599455, 2602729, 2605035, 2606707, 2608757, 2614031, 2616153, 2618045, 2620408, 2622735, 2623070, 2628694, 2629838, 2633563, 2634788, 2637813, 2638899, 2639802, 2641868, 2642796, 2642797, 2645304, 2648615, 2651105, 2651106, 2524272, 2527606, 2538198, 2541914, 2541925, 2544254, 2567876, 2568983, 2573850, 2583927, 2591050, 2591051, 2597822, 2602735, 2606708, 2615193, 2618046, 2620409, 2627501, 2629839, 2632525, 2634789, 2638910, 2639803, 2642798, 2645305, 2647760, 2538199, 2538200, 2541926, 2541927, 2541928, 2544260, 2545246, 2573846, 2583928, 2591076, 2597823, 2601623, 2610484, 2617667, 2622736, 2627924, 2629840, 2634790, 2639808, 2639809, 2642799, 2646184, 2647761, 2648617, 2651108
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Domestic: AK, AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MS, MA, MD, ME, MI, MN, MO, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY International: Canada, Japan
  • Product Description
    Biolox Delta Femoral Head - The BIOLOX delta Ceramic Femoral Head is used in conjunction with compatible acetabular and femoral stem components in total hip arthroplasty. A variety of sizes and neck lengths are available for various patient anatomies and adjustment of the tension of the ligaments and reconstruction of the center of the natural head of the femur.
  • Manufacturer
  • Model / Serial
    Item No. 00-5852-052-10; Lot 62866438
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution to the state of TX
  • Product Description
    Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem || Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented.
  • Manufacturer
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