Events

Recall of Device Recall Biomet Comprehensive Reverse Shoulder Humeral

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zimmer Biomet, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    75971
  • Event Risk Class
    Class 1
  • Event Number
    Z-1103-2017
  • Event Initiated Date
    2016-12-20
  • Event Date Posted
    2017-02-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151859
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented - Product Code PAO
  • Reason
    Higher than anticipated rate of fracturing due to design. risk of revision surgery due to fracturing.
  • Action
    On 12/20/2016, URGENT MEDICAL DEVICE RECALL-LOT SPECIFIC notifications were sent to the affected Risk Managers and Distributors via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. On 2/1/2017, URGENT MEDICAL DEVICE RECALL-LOT SPECIFIC notifications were sent to the affected Surgeons, Risk Managers, and Distributors via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. The 2/1/2017 notice identified additional product lots that had been added to the affected product list, as well as included patient monitoring guidance for surgeons.

Device

Device Recall Biomet Comprehensive Reverse Shoulder Humeral
  • Model / Serial
    Lot numbers 016140 026690 041870 041880 041890 049710 049740 052860 060500 070330 075330 085130 118250 118260 118270 118280 118290 118300 118340 118350 118360 118370 118380 118390 132020 132030 153330 153340 153350 153360 153370 153380 153390 153400 153410 153420 153430 159650 159660 161960 172670 208280 208290 212200 212230 212240 215990 216000 216010 228630 228640 228650 228660 228670 256990 257000 257010 257020 278300 278310 278320 278330 278550 278560 278580 278590 300090 300100 300110 300120 300130 300140 300150 307790 310580 310590 310600 310610 310620 320150 329390 334260 334370 349140 349150 351030 351040 359610 359630 359640 359650 359660 359680 361860 361870 361880 361890 361900 367300 367310 367320 367330 367340 367350 367360 367370 367380 372290 372310 372320 384350 385090 391660 402880 411980 413530 415040 415050 415060 415070 415080 415090 420630 424640 424650 424660 424670 424680 424690 424700 424710 424720 424730 424740 433020 433030 433040 433050 433590 436760 436770 440500 457900 473090 479360 479370 479380 482000 482010 492370 492380 492390 492400 492410 492420 492430 492440 492450 501830 525910 525920 541880 541890 541900 551660 555280 556000 556360 556460 556800 556820 557390 557440 557520 557620 557760 557790 557830 557840 558000 558040 558840 558880 558890 558900 558910 558920 561530 561560 561790 561890 561910 561950 562430 563440 568870 569050 569070 569080 569090 569100 569120 569130 569140 569150 569690 575100 578920 595090 597740 597970 600320 607390 607400 607410 607420 607430 609780 613990 630660 630690 633570 633600 634660 634670 634860 634870 635190 635820 637190 637240 637250 641220 641350 641390 641680 648790 648800 648810 648820 648830 648860 659950 659960 659970 659980 659990 660000 660010 660020 660030 660040 668550 668560 668570 668580 668590 668600 668610 668620 668630 668970 674320 677090 677100 677110 677140 677150 677160 677170 677180 677190 677200 679060 679070 680720 680730 680740 680750 680760 683040 695900 695920 696270 696280 696290 696300 696310 696320 697100 697110 697120 697130 697150 697160 697170 697180 697190 697200 704050 704440 704810 706840 712090 715990 716200 723830 723850 723860 723870 723880 725550 725560 725760 725800 726590 726710 734810 745350 762700 762930 764700 765560 765830 765870 767250 767260 767270 767360 767370 771810 788670 788680 788690 791260 791270 791280 818790 839150 840600 840610 846190 846200 846210 846230 846240 846280 846290 846300 846310 846320 846330 848110 848120 848130 848140 848150 848160 848170 848190 848200 848210 848220 848230 848240 848250 848260 848270 848280 848290 848300 848310 848320 854210 854220 854240 854250 854260 854290 854300 854310 854320 863330 870120 876790 889690 905280 905340 906550 908010 917830 918800 927760 934930 950390 950400 963700 974990 981260 981270 997320 997330
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide. CANADA AUSTRALIA CHILE COLOMBIA KOREA Netherlands
  • Product Description
    Comprehensive Reverse Shoulder System Humeral Tray || Model 115340
  • Manufacturer
    Zimmer Biomet, Inc.

Manufacturer

Zimmer Biomet, Inc.
  • Manufacturer Address
    Zimmer Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • 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