Magna-Fx Cannulated Screw Fixation System 7.0 mm. Item codes starting with 0011420, 11460 and 11461.
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
- 60678937 60725698 60820102 60868357 61099266 61122455 61286984 60356456 60780951 60962055 61041381 61099267 61115876 61197682 60101457 60165562 60207649 60218165 60678939 60714704 60780952 60868358 60932395 61010681 61013650 61107937 61185828 61261813 60154179 60242174 60392816 60714705 60735829 60820103 60861042 60914270 60962060 61030191 61031913 61099268 61107952 61129838 61286986 62311946 60116999 60137567 60264359 60392817 60686417 60735830 60962064 61107953 61144212 61291484 62326539 60137568 60381037 60452034 60678940 60725699 60861044 60885486 61030192 61064420 61107954 61144213 61291485 61627268 62320020 60099553 60124830 60155276 60210916 60279193 60293173 60406084 60678941 60735831 60772796 60820105 60914273 60932397 60962068 61100754 61107955 61141540 61383124 61542613 60099554 60123327 60151759 60165563 60186810 60218909 60323277 60337989 60392818 60641792 60700524 60776686 60861046 60885488 60914275 60932398 61041383 61064421 61107956 61122465 61383125 61523983 61549785 60097901 60151760 60167122 60231230 60242175 60338000 60374541 60678943 60690724 60700525 60820107 60863688 60962072 60997213 61041385 61099269 61107957 61122466 61162278 61185825 60097903 60151761 60186811 60231231 60338011 60374542 60502481 60735832 60776688 60787138 60997215 61099270 61115884 61180535 61282213 62294111 60154180 60172533 60242176 60309839 60381041 60452035 60502489 60735833 60938330 61062712 61064422 61107958 61122467 61141541 61549786 61699534 60099555 60165564 60201193 60242177 60356457 60502490 60735834 60820109 61041387 61099271 61115885 61180536 60137569 60172535 60218167 60264360 60274085 60538627 60569295 60585920 60749370 60861047 60868423 61099273 61122468 61141542 61180537 61466708 61542615 61721886 60279194 60293174 60545074 60588248 60735835 60755954 60820110 61067734 61107959 61122469 61162279 61185824 61513918 61542616 61699535 61707903 60127526 60167124 60264361 60274087 60452036 60569296 60678944 60749371 60820111 60863690 60868424 60962076 61030196 61031914 61107960 61141543 61141544 61286988 61310672 61664669 61728752 60111974 60135187 60159631 60172537 60207650 60242178 60264362 60274088 60333855 60538628 60588250 60714706 60755955 60772797 60820112 60868425 60885490 61031915 61041388 61062715 61099274 61122470 61129839 61197683 61226805 61249292 61268913 61387106 61420556 61428556 61499991 61530368 61549787 61693583 62280871 60109521 60152938 60167125 60218910 60293175 60323278 60333856 60543510 60569297 60585921 60735836 60780960 60820113 60861048 61013653 61066995 61107961 61122472 61129840 61261814 61286989 61453602 61542618 61696617 62294114 60096585 60101458 60132538 60152939 60165565 60215885 60264363 60274089 60381042 60404762 60452038 60538629 60545075 60588251 60700527 60735837 60755956 60787139 60868426 60885493 60997219 61028537 61049507 61092285 61100755 61141545 61141546 61180538 61245893 61268914 61383126 61453603 61542619 61627271 61693574 61728754 61728755 60123331 60140271 60154181 60195116 60218912 60264364 60274090 60293176 60333857 60413633 60514795 60525792 60526406 60545076 60585923 60780961 60820114 60868427 60885494 60962080 60997222 61030197 61031916 61049518 61092287 61099276 61141547 61141548 61197684 61245895 61261815 61286991 61309368 61383128 61420557 61453604 61473782 61523985 61627272 61664672 61700331 61707928 61728757 62294115 60109522 60123334 60152940 60218914 60279203 60293177 60392819 60406085 60413634 60525793 60526411 60588252 60749372 60780964 60787144 60863692 60868428 60885497 60962081 60998278 61041389 61066997 61099277 61107962 61144214 61206712 61226806 61261816 61286992
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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