12/14 UNIPOLAR FEMORAL HE VERSYS CEM LD/FX SZ 11X12 VERSYS CEM LD/FX SZ 12X12 VERSYS CEM LD/FX SZ 14X13 VERSYS CEM LD/FX SZ 16X14 VERSYS CEM LD/FX ST 18X15 VERSYS PRESS FIT LD/FX ST VERSYS PRESS FIT LD/FX SZ VERSYS ADVOCATE CEMENTED VERSYS ADVOCATE V-LIGN CE VERSYS CEMENTED FEM STEM VERSYS CT FEM STEM 11X120 VERSYS CT FEM STEM 12X125 VERSYS CT FEM STEM 13X130 VERSYS CT FEM STEM 14X135 VERSYS CT FEM STEM 15X140 VERSYS CT FEM STEM 16X145 VERSYS CT FEM STEM 17X150 VERSYS CEM/REV/CALCAR 13X VERSYS CEM/REV/CALCAR 15X VERSYS CEM/REV/CALCAR 17X VERSYS CEM/REV/CALCAR 19X
Published February 26, 2014 · Recall initiated: October 11, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer, Inc.
- Distributor
- Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.
- Lot
- 365717 366402 367390 368994 369213 369214 369215 369319 370354 370750 371011 60109630 60142945 60235507 60273068 60339025 60448362 60554135 60784634 60800920 60819863 60884374 60902584 60943291 60971162 60988528 61070891 61100359 61100360 61176577 61176578 61176579 61632276 61765960 61814863 365718 367382 368346 368981 369034 369220 369221 369268 369269 369320 370432 370439 370542 370733 60114244 60206094 60222003 60282832 60334506 60448361 60554138 60651808 60697870 60737518 60784635 60800012 60819864 60819866 60843493 60866926 60884376 60884377 60928161 60943290 60988523 60997305 60997308 61013936 61013938 61171992 61171994 61171995 61176581 61176582 62124063 62256027 365719 367386 368347 369032 369209 369212 369216 369321 369425 369777 369793 370009 370139 370355 370440 370543 370747 371010 60105214 60105215 60118794 60134658 60150050 60191183 60197679 60217131 60222017 60262516 60280674 60322647 60339026 60362643 60407176 60451001 60535945 60559829 60587995 60597421 60691785 60713743 60756664 60784637 60797521 60810339 60838414 60854443 60866927 60902585 60909206 60928153 60943284 60961115 60961116 60997298 60997302 61013941 61070892 61100361 61100362 61176583 61176587 61284588 61330548 61565671 61633857 61748978 61758460 62010702 62079124 62109109 62200261 62251993 62287497 365720 367387 368348 368993 369033 369266 369267 369322 369426 369794 370011 370147 370356 370441 370544 370734 371009 60118795 60134659 60134660 60150052 60176098 60176099 60191978 60197704 60215816 60218181 60224979 60239685 60262517 60265792 60278841 60294265 60322588 60322648 60339027 60356036 60381913 60381933 60407169 60429439 60446325 60476575 60508194 60529659 60535946 60559830 60574968 60597422 60619977 60645475 60651960 60691790 60709222 60727029 60752694 60758477 60785503 60810318 60822017 60822018 60838415 60862041 60866929 60866930 60909208 60943285 60943288 60943289 60988552 60997310 61019080 61022707 61066053 61066055 61100363 61100364 61135473 61176591 61176592 61206721 61245068 61256746 61256747 61266194 61284589 61284591 61330550 61459592 61459593 61522123 61522124 61522125 61633856 61638073 61664545 61727694 61748979 61801229 61907162 61910387 61957518 62006565 62016718 62028864 62109112 62124062 62146104 62200264 62211989 62226926 62287498 365721 368349 368992 369264 369323 369795 370012 370357 370442 370873 60105216 60105231 60105234 60105236 60105243 60105245 60105247 60138468 60150053 60150054 60169633 60173093 60173094 60184844 60187360 60187361 60191979 60197712 60197724 60215817 60217132 60219715 60224980 60231511 60239675 60239686 60243991 60255167 60262525 60265794 60265837 60278842 60288779 60294247 60294266 60308775 60308783 60322649 60337533 60346339 60346343 60362635 60362652 60381914 60381924 60392723 60392739 60407171 60423105 60425449 60429440 60442530 60451002 60476576 60508195 60508196 60508197 60529660 60529661 60541677 60541678 60559831 60568797 60574969 60586046 60588011 60605069 60614403 60619978 60619979 60638886 60645469 60651961 60656927 60663367 60670455 60680880 60691797 60691798 60709223 60713744 60713745 60727030 60732783 60756665 60758478 60773993 60773994 60785506 60796175 60800921 60810330 60822019 60822020 60833907 60844095 60847596 60854447 60862042 60866931 60866932 60928169 60928170 60928171 60971148 60971149 60971150 60988559 60988561 61013955 61013957 61013959 61019081 61066056 61066057 61070893 61100365 61100366 61100367 61115195 61135474 61180476 61180489 61180491 61180492 61180497 61187389 61229650 61229651 61245355 61245372 61256748 61256749 61273827 61273828 61284592 61284593 61304641
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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