Events

Recall of Device Recall Zimmer

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

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
    72900
  • Event Risk Class
    Class 2
  • Event Number
    Z-1144-2016
  • Event Initiated Date
    2016-01-11
  • Event Date Posted
    2016-03-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143755
  • 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
    Screw, fixation, bone - Product Code HWC
  • Reason
    As a result of the insufficient sealer calibration data for product packaged in firm's building ii between august 2010 and april 2013. the affected products are sterile.
  • Action
    Zimmer Biomet sent an Urgent Medical Device Recall Letter, dated January 11, 2016, to Distributors, Sales Representatives, Operation Managers, and Risk Managers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to 1.Review the notification and ensure that relevant personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative with the quarantine of any affected product. 3. Your Zimmer Biomet sales representative will remove the recalled product from your facility. 4. Complete and return the attached Certificate of Acknowledgment form to corporatequality.postmarket@zimmerbiomet.com. 5. If after reviewing this notification you have further questions or concerns please call Customer Service at 1-800-348-2759, or contact your Zimmer Biomet Sales Representative.

Device

Device Recall Zimmer
  • Model / Serial
    lot no.: 62083732 62278719 62278734 62346023 62351544 62346023N 62351544N 61885643 62239545 62239546 62239547 62239548 62290035 62290040 61890456 62005296 62223791 62299098 62346024 61910239 62178894 62346025 61930882 62157290 62248127 62326540 61759543 61892650 61958361 62178895 62346026 62346027 62346026N 62346027N 61627269 61740666 61870977 62079036 62110010 62178896 62234077 62234078 62234079 62234080 62234081 62234082 62234084 62340974 62340975 62340978 62340980 62340983 62344456 62344457 62344459 62344460 62340974N 62340975N 62340978N 62340980N 62340983N 62344456N 62344457N 62344459N 62344460N 61620146 61740667 61839169 61930883 62083735 62223795 62339582 62339585 62339586 62339588 62339589 62339590 62339585N 62339586N 62339588N 62339589N 62339590N 61664666 61759547 61885657 61930884 62083738 62248129 62334669 62334674 62334676 62334680 62337028 62337030 62346148 62351545 62334669N 62334674N 62334680N 62337030N 62346148N 62351545N 61755871 61842980 61950125 62110013 62332636 62336795 62337610 62340759 61719688 61740668 61764765 61889321 61930885 61958362 62110016 62197619 61842575 61885662 61910240 61958364 62005298 62131627 62248131 61664668 61740669 61809454 61870981 61870982 61942560 61952205 62074451 62109223 62168534 62168536 62193745 62281959 61835310 61835311 61870983 61930887 61958365 62031613 62118362 62168528 62168530 62193746 62193747 61839170 61862390 61930889 61940170 61956896 62005299 62074448 62107919 62144850 62144851 62193749 62223801 61740670 61798065 61839171 61862397 61862398 61892651 61930890 61942566 61951771 61999816 61999817 62079037 62110024 62168522 62168524 62197620 62197621 62239549 61620147 61788220 61788221 61840997 61885668 61885672 61950128 62031606 62106211 62144736 62144739 62144740 62197622 62197623 61809455 61836434 61840999 61841001 61870989 61870990 61870991 61910905 61930891 61942589 61952206 62005300 62005301 62079035 62112478 62144853 62144855 62144856 62178897 62200611 62239550 62281962 61752988 61798071 61839182 61839183 61841007 61870994 61870996 61892652 61910906 61942608 61942623 61952207 62005302 62005303 62079038 62110026 62144857 62144858 62144859 62178035 62178036 62193750 62346172 61597056 61740671 61764764 61798218 61809459 61839173 61862399 61862401 61882161 61882163 61910907 61910908 61950130 61952208 62005304 62005305 62106213 62137880 62137881 62177728 62177731 62193751 62200613 62281964 61664674 61740674 61752994 61839174 61862402 61862403 61882151 61882152 61930892 61950131 61952209 61956897 62074443 62074446 62107920 62112480 62137882 62137883 62168525 62168526 62168527 62193752 62200614 62203872 62203873 61678585 61728762 61759552 61809458 61839175 61870997 61870999 61871000 61941064 61941065 61952210 61999818 61999819 62083740 62083742 62112841 62137884 62177729 62193753 62197624 62239551 61740675 61740676 61759553 61839180 61862405 61862406 61862407 61890459 61890463 61930899 61930903 61952211 61952212 62005306 62005307 62106210 62112481 62137885 62137886 62178898 62178901 62200616 62239552 61664677 61700334 61728770 61728771 61752995 61836438 61841002 61862408 61862409 61882142 61882148 61882149 61930904 61930905 61952213 61952214 62005308 62031609 62086295 62110027 62144894 62144895 62144896 62144897 62144898 62178037 62178038 62223803 61740677 61809457 61836439 61841003 61871002 61892653 61930906 61956899 62074454 62168531 62168532 62193754 62193755 62193756 61664679 61728772 61752993 61836440 61839181 61871003 61889322 61930913 61952215 62005309 62005310 62079032 62086297 62107922 62157241 62157243 62168889 62200617 62223805 61740678 61752990 61836441 61841004 61871004 61871005 61889323 61892654 61993234 61993258 61993259 62083744 62083745 62110028 62177730 62197625 61740679 61809456 61836446 61841009 61871017 61871018 61930952 61956898 62005311 62083746 62116884 62197626 62197627 61740680 61836455 61841011 61885676 61930968 61999820 62107923 62168538 62197628 61759555 61836462 61836463 61871019 61930989 61993235 61993262 62144899 62223808 61898926 62023136 61889523 61803794 61897121 61862328 62181490 62248132 61862329 62248134 61897120 62248135 61898927 62023139 61862337 61948708 62157282 61898930 62181499 61761438 61803784 61908063 62181502 61908064 62112490 61941077 61803795 61895060 62248142 61804613 61889332 62181507 61862341 62086313 62248155 61803785 61895062 62181469 61898936 62112491 61842578 61896723 61948709 62112492 62268720 61804615 61908066 62112493 62181484 61664652 61804616 61842579 61862345 61896729 61941078 62086320 61620149 61678576 61842580 61908070 62112495 61804618 61889364 62023141 61740653 61842581 61910238 62086316 62248159 61787812 61897119 61908072 61740655 61842577 61895063 61897118 62086318 62181524 61664661 61809460 61895064 61941080 62086319 62248165 61842576 61862349 61941081 62086323 61749564 61842582 61895066 62023144 61842592 61862353 61897117 62086324 62181528
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution
  • Product Description
    Product 46 consists of all product under product code: HWC and same usage: || Item no: || 114204012 MINI MAGNA-FX CANN SCREW || 114204016 MINI MAGNA-FX CANN SCREW || 114204020 MINI MAGNA-FX CANN SCREW || 114204024 MINI MAGNA-FX CANN SCREW || 114204028 MINI MAGNA-FX CANN SCREW || 114204032 MINI MAGNA-FX CANN SCREW || 114204036 MINI MAGNA-FX CANN SCREW || 114204040 MINI MAGNA-FX CANN SCREW || 114204044 MINI MAGNA-FX CANN SCREW || 114204048 MINI MAGNA-FX CANN SCREW || 114204055 MINI MAGNA-FX CANN SCREW || 114204065 MINI MAGNA-FX CANN SCREW || 114204124 MINI MAGNA-FX CANN SCREW || 114204126 MINI MAGNA-FX CANN SCREW || 114204128 MINI MAGNA-FX CANN SCREW || 114204130 MINI MAGNA-FX CANN SCREW || 114204132 MINI MAGNA-FX CANN SCREW || 114204134 MINI MAGNA-FX CANN SCREW || 114204136 MINI MAGNA-FX CANN SCREW || 114204138 MINI MAGNA-FX CANN SCREW || 114204140 MINI MAGNA-FX CANN SCREW || 114204142 MINI MAGNA-FX CANN SCREW || 114204144 MINI MAGNA-FX CANN SCREW || 114204146 MINI MAGNA-FX CANN SCREW || 114204148 MINI MAGNA-FX CANN SCREW || 114204150 MINI MAGNA-FX CANN SCREW || 114204155 MINI MAGNA-FX CANN SCREW || 114204160 MINI MAGNA-FX CANN SCREW || 114204165 MINI MAGNA-FX CANN SCREW || 114204170 MINI MAGNA-FX CANN SCREW || 114205012 MINI MAGNA-FX CANN SCREW || 114205016 MINI MAGNA-FX CANN SCREW || 114205020 MINI MAGNA-FX CANN SCREW || 114205024 MINI MAGNA-FX CANN SCREW || 114205028 MINI MAGNA-FX CANN SCREW || 114205032 MINI MAGNA-FX CANN SCREW || 114205036 MINI MAGNA-FX CANN SCREW || 114205040 MINI MAGNA-FX CANN SCREW || 114205044 MINI MAGNA-FX CANN SCREW || 114205048 MINI MAGNA-FX CANN SCREW || 114205055 MINI MAGNA-FX CANN SCREW || 114205065 MINI MAGNA-FX CANN SCREW || 114205124 MINI MAGNA-FX CANN SCREW || 114205126 MINI MAGNA-FX CANN SCREW || 114205128 MINI MAGNA-FX CANN SCREW || 114205130 MINI MAGNA-FX CANN SCREW || 114205132 MINI MAGNA-FX CANN SCREW || 114205134 MINI MAGNA-FX CANN SCREW || 114205136 MINI MAGNA-FX CANN SCREW || 114205138 MINI MAGNA-FX CANN SCREW || 114205140 MINI MAGNA-FX CANN SCREW || 114205142 MINI MAGNA-FX CANN SCREW || 114205144 MINI MAGNA-FX CANN SCREW || 114205146 MINI MAGNA-FX CANN SCREW || 114205148 MINI MAGNA-FX CANN SCREW || 114205150 MINI MAGNA-FX CANN SCREW || 114205155 MINI MAGNA-FX CANN SCREW || 114205160 MINI MAGNA-FX CANN SCREW || 114205165 MINI MAGNA-FX CANN SCREW || 114205170 MINI MAGNA-FX CANN SCREW || Product Usage: || A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
  • Manufacturer
    Zimmer Manufacturing B.V.

Manufacturer

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