Date Initiated by Firm | January 11, 2016 |
Date Posted | March 12, 2016 |
Recall Status1 |
Terminated 3 on April 13, 2017 |
Recall Number | Z-1152-2016 |
Recall Event ID |
72900 |
510(K)Number | K991581 |
Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
|
Product | Product 54 consists of all product under product code: JWH and same usage:
Item no:
596009900 NEXGEN TAPER PLUG
for use in total knee arthroplasty |
Code Information |
lot no.: 61390872 61761213 61780493 61780494 61780495 61780496 61780497 61789111 61789112 61789113 61789114 61789115 61789116 61789117 61789118 61789119 61789120 61789121 61789122 61789123 61789124 61789125 61789126 61789127 61789128 61789129 61789130 61789131 61789132 61789133 61789134 61789135 61789136 61789137 61789138 61789139 61789140 61789141 61789142 61798737 61798738 61798739 61798740 61798741 61798742 61798743 61798744 61798745 61798746 61799383 61799384 61799385 61799386 61799387 61799388 61799389 61799390 61799391 61799392 61803606 61803607 61803608 61803609 61803610 61803611 61803612 61803613 61803614 61803615 61807320 61807321 61807322 61807323 61807324 61807325 61807326 61807327 61807328 61807329 61807330 61809795 61809796 61809797 61809798 61809799 61809801 61809802 61809803 61809804 61809805 61816959 61816960 61816961 61816962 61816963 61816964 61816965 61816966 61816967 61816968 61816969 61816970 61816971 61816972 61816973 61816974 61816975 61821036 61821037 61821038 61821039 61821040 61821041 61821042 61821043 61821044 61821645 61821646 61821647 61821648 61821649 61821650 61821651 61821652 61821653 61821654 61821655 61821656 61824212 61824213 61824214 61824215 61824218 61824219 61824220 61824221 61824222 61824223 61824224 61824225 61824226 61841214 61841215 61841216 61841217 61841218 61841219 61841220 61841221 61841222 61841223 61841224 61841225 61841226 61841227 61841228 61853071 61853072 61853073 61853074 61853075 61853076 61853077 61853078 61853079 61853080 61854884 61854885 61854886 61854887 61854888 61854889 61854890 61854891 61854892 61854893 61854895 61854896 61854897 61854898 61854899 61854901 61854902 61854903 61854904 61854908 61859266 61859267 61859268 61859269 61859270 61859271 61859272 61859273 61859274 61859275 61859276 61859277 61859278 61859279 61859280 61861407 61861408 61861409 61861410 61861411 61861412 61861413 61861414 61861415 61861416 61861417 61861418 61862838 61862839 61862840 61862841 61862842 61862843 61862844 61862845 61862846 61862847 61862848 61866424 61866425 61866426 61866427 61866428 61866429 61866430 61866431 61866432 61866433 61866434 61866435 61866436 61866437 61866438 61870201 61870202 61870203 61870204 61870205 61870206 61870207 61870208 61870209 61870210 61870211 61870212 61871207 61871208 61871209 61871210 61871211 61871212 61871213 61871214 61871215 61871216 61873871 61873872 61873873 61873874 61873875 61873876 61873877 61873878 61873879 61873880 61875868 61875869 61875870 61875871 61875872 61875873 61875874 61875875 61875876 61875877 61875878 61875880 61880159 61880160 61880161 61880162 61880163 61880164 61880165 61880166 61880167 61880168 61881871 61881874 61881877 61881879 61881882 61881884 61884227 61884228 61884229 61884230 61884231 61884232 61884233 61884234 61884235 61884236 61888309 61888310 61888311 61888312 61888313 61888314 61888315 61888316 61892499 61892501 61892502 61892503 61892504 61892505 61892506 61892507 61892508 61892509 61894659 61894660 61894661 61894662 61894663 61894664 61894665 61894666 61894667 61894668 61894669 61894670 61896436 61896437 61896438 61896439 61896440 61896441 61896442 61896443 61896444 61896445 61896446 61896447 61900676 61900677 61900678 61900679 61900680 61900681 61900683 61900684 61900685 61900686 61900687 61901096 61901097 61901098 61901099 61901101 61901102 61901103 61901104 61901105 61901106 61906166 61906167 61906169 61906170 61906171 61906172 61906173 61906174 61906175 61906176 61907580 61907581 61907582 61907583 61907584 61907585 61907586 61907587 61907588 61907589 61907590 61907591 61909573 61909574 61909575 61909576 61909577 61909578 61909579 61909580 61909581 61912019 61912020 61912021 61912022 61912023 61912024 61914595 61914596 61914597 61914598 61914599 61914601 61914602 61914604 61914606 61914607 61914608 61914609 61914610 61918370 61918371 61918372 61918373 61918374 61918375 61918376 61918377 61918378 61918379 61921499 61921501 61921502 61921503 61921504 61921505 61921506 61921507 61921508 61921509 61921510 61921511 61921512 61921513 61921514 61925785 61925786 61925787 61925788 61925789 61925790 61925791 61925792 61925793 61925794 61925795 61925796 61925797 61925798 61925799 61925801 61925802 61925803 61925804 61925805 61929843 61929844 61929845 61929846 61929847 61929848 61929849 61929850 61929851 61929852 61932586 61932587 61932588 61932589 61932590 61932591 61932592 61932593 61932594 61932595 61935605 61935606 61935607 61935608 61935609 61935610 61935611 61935612 61935613 61935614 61935615 61935616 61935617 61935618 61935619 61935620 61935621 61935622 61935623 61935624 61935625 61935626 61935627 61935628 61935629 61935630 61935631 61935632 61935633 61945859 61945860 61945861 61945862 61945863 61945864 61945865 61945866 61945867 61945868 61949860 61949861 61949862 61949863 61949864 61949865 61949866 61949867 61949868 61949869 61949870 61949871 61954555 61954556 61954557 61954558 61954559 61954560 61954561 61954562 61954563 61954564 61954565 61954566 61954567 61954568 61954569 61954570 61958064 61958065 61958066 61958067 61958068 61958069 61958070 61958071 61958072 61958073 61958074 61958075 61958076 61958077 61958078 61958079 61962944 61962945 61962946 61962947 61962948 61962949 61962950 61962951 61962952 61962953 61962954 61964608 61964609 61964610 61964611 61964612 61964613 61964614 61964615 61964616 61964617 61964618 61964619 61968215 61968216 61968217 61968218 61968219 61968220 61968221 61968222 61968223 61968224 61968225 61968226 61968227 61968229 61976622 61976623 61976624 61976625 61976626 61976627 61976628 61976629 61976630 61979888 61979889 61979890 61979891 61979892 61979893 61979894 61979895 61979896 61979897 61979898 61979899 61979901 61979902 61979903 61979904 61984234 61984235 61984236 61984237 61984238 61984239 61984240 61984241 61984242 61984243 61986444 61986445 61986446 61986447 61986448 61986449 61987774 61987775 61987776 61987777 61987779 61987780 61987781 61992966 61992967 61992968 61992969 61992970 61992971 61992972 61992973 61992974 61992975 61996287 61996288 61996289 61996290 61996291 61996292 61996293 61996294 61996295 61996296 62005105 62005106 62005107 62005108 62005109 62005110 62005111 62005112 62005113 62005114 62006480 62006482 62006483 62006484 62006485 62006486 62006487 62006488 62006489 62006490 62006491 62006492 62006493 62006494 62006495 62006497 62006498 62006499 62006500 62006501 62006502 62006503 62006504 62011884 62011885 62011886 62011887 62011888 62011889 62011890 62011891 62011892 62011893 62011894 62011895 62011896 62011897 62011898 62011899 62011900 62011901 62011910 62011911 62011912 62011913 62011914 62011915 62011916 62011918 62011919 62021221 62021222 62021223 62021224 62021225 62021226 62021227 62021228 62021229 62027286 62027287 62027288 62027289 62027290 62027291 62027293 62027294 62027295 62027296 62027297 62027364 62027365 62027366 62027367 62027368 62036561 62036563 62036564 62036567 62036568 62036569 62036570 62036571 62040067 62040068 62040069 62040070 62040071 62040072 62043925 62043926 62043927 62043928 62043929 62043931 62043932 62048456 62048457 62048458 62048459 62048460 62048461 62048462 62048463 62048796 62048797 62048798 62048799 62048801 62048802 62048803 62048804 62048805 62048806 62059432 62059433 62059434 62059435 62059436 62065417 62065418 62065420 62065421 62065422 62065423 62065424 62065425 62065426 62065427 62065428 62066411 62066412 62066413 62066414 62066415 62078397 62078398 62078399 62078401 62078403 62081029 62081030 62081031 62081032 62081033 62085508 62085509 62085510 62085511 62085512 62087723 62087724 62087725 62087726 62089860 62089861 62089862 62089863 62089864 62089865 62092715 62092716 62092717 62092718 62092719 62093306 62093308 62093309 62093310 62093311 62098120 62098121 62098122 62098123 62098124 62100822 62100823 62100824 62100825 62100826 62100827 62100828 62100829 62100830 62100831 62106273 62106274 62106275 62106276 62106277 62106278 62106279 62106280 62106281 62106282 62112482 62112483 62112484 62112485 62112486 62112487 62112488 62112489 62119093 62119094 62119095 62119096 62119097 62119098 62119099 62119102 62126593 62126594 62126595 62126596 62126597 62126598 62133506 62133507 62133508 62133509 62133510 62133511 62133512 62133513 62133514 62133515 62133516 62133517 62142309 62142310 62143202 62143203 62143204 62143205 62143206 62143207 62143208 62143209 62143210 62144720 62144721 62144722 62144723 62144724 62144725 62150660 62150661 62150662 62150663 62150664 62150665 62150666 62150667 62157271 62157272 62157273 62157274 62157275 62160729 62160730 62160731 62160732 62160733 62160734 62160735 62160736 62160737 62160738 62160739 62160740 62160741 62160742 62167342 62167343 62167344 62167345 62167346 62167347 62167348 62167349 62170346 62170347 62170348 62170349 62170350 62170351 62170352 62170353 62173199 62173201 62173202 62173203 62180885 62180886 62180887 62180888 62180889 62180890 62180891 62180892 62180893 62180894 62180895 62180896 62187725 62187726 62187727 62187728 62187729 62190273 62190274 62190275 62190276 62190277 62190278 62190279 62190280 62190281 62190282 62193990 62193991 62193992 62193993 62193994 62193995 62193996 62198106 62198107 62198108 62198110 62199702 62199703 62203929 62203930 62203931 62203932 62203933 62203934 62203935 62203936 62203937 62203938 62211030 62211031 62211032 62211033 62211034 62211482 62211483 62211484 62211485 62211486 62211487 62211488 62211489 62211490 62211491 62211492 62211493 62211494 62211495 62211496 62221194 62221195 62221196 62221197 62221198 62221199 62221201 62221202 62221203 62221204 62221205 62221206 62221207 62221208 62221209 62221210 62221211 62221212 62221213 62221214 62227235 62227236 62227237 62227239 62227240 62227241 62227242 62227243 62227244 62227245 62227615 62227616 62227617 62227618 62227619 62227620 62227621 62227622 62241528 62241529 62241530 62241531 62241532 62241533 62241534 62241535 62241536 62241537 62248334 62248335 62248336 62248337 62248338 62248339 62248340 62248341 62248342 62248343 62248344 62248345 62248346 62248347 62248348 62249991 62249992 62249993 62249994 62249995 62249996 62249997 62249998 62249999 62250001 62250002 62250003 62250004 62250005 62250006 62250007 62263075 62263076 62263077 62263078 62263079 62263080 62263081 62263082 62263083 62263084 62263085 62263086 62263087 62263088 62263089 62263090 62263091 62263092 62263093 62263094 62267801 62267802 62267803 62267804 62267805 62267806 62267807 62267808 62267809 62267810 62283349 62283351 62283355 62283356 62283357 62283358 62283359 62283361 62283362 62283363 62283364 62283365 62283366 62283367 62283371 62283372 62283373 62283374 62283376 62283377 62283378 62283379 62283380 62283382 62283383 62283384 62297247 62297248 62297249 62297250 62297251 62297252 62297253 62297254 62297255 62297256 62297257 62297258 62297259 62297260 62297261 62303411 62303413 62303414 62303415 62303416 62303417 62303418 62303419 62303420 62303421 62303422 62315387 62315388 62315389 62315390 62315391 62318077 62318078 62318079 62318080 62318081 62318082 62318083 62319328 62319329 62319330 62319331 62319332 62319333 62319334 62319335 62319336 62319337 62326417 62326418 62326556 62326557 62326558 62326559 62326560 62328726 62328727 62328728 62328729 62328730 62328731 62328732 62328733 62330898 62330899 62330901 62330902 62330903 62330904 62330905 62330907 62330908 62330909 62330910 62330911 62330912 62330913 62330914 62330915 62339023 62339024 62339025 62339026 62339027 62339028 62339029 62339030 62339031 62339032 62303414N 62318081N 62319328N 62326418N 62326559N 62328727N 62330902N 62330911N 62330915N |
Recalling Firm/ Manufacturer |
Zimmer Manufacturing B.V. Turpeaux Industrial Park Rd 1 km 123.4 Mercedita PR 00715
|
For Additional Information Contact | Consumer Relations Call Center 800-447-5633 |
Manufacturer Reason for Recall | 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. |
FDA Determined Cause 2 | Packaging |
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. |
Quantity in Commerce | 1767 |
Distribution | US Nationwide Distribution |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = JWH
|