RECON SCREW LG 5.5MM DIA and M/DN FEM IM NAIL 8MM DIA to 16 MM DIA. Item codes starting with 0022520, 0022521, 002522, 0022523, 0022524 and 0022525.
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
- 60177183 60185167 60358113 60497829 60497830 60505959 60537292 60537294 60575711 60620308 60714139 60725700 60817575 60863968 60876909 61031020 61075699 61140183 61178962 61286463 61475180 61530431 60099578 60152959 60185168 60265704 60279629 60358114 60461498 60497831 60505960 60537296 60550315 60575712 60602426 60615919 60690735 60714140 60735634 60857991 60863973 60950791 60966531 61104682 61175267 61194460 61453383 61489974 60099579 60185169 60195438 60265705 60279630 60358115 60380439 60450626 60497832 60505961 60537298 60569917 60575713 60602428 60615938 60711131 60735635 60819473 60857992 60863980 61024758 61066603 61075700 61133155 61158610 61175268 61178939 61242313 61258929 61280067 61303205 61446260 61484472 61604368 61664930 60152960 60177184 60185170 60208612 60279631 60323289 60450628 60461502 60461503 60505962 60537299 60537301 60569919 60602430 60615936 60714142 60735636 60819454 60857994 60863981 60876912 61041742 61071417 61120273 61143242 61158614 61175269 61178942 61256011 61303206 61414385 61439695 61446261 61512407 61530432 61551620 62296412 60095053 60117030 60123298 60137565 60152961 60167141 60185171 60208614 60279632 60301507 60367530 60450630 60451182 60461504 60461505 60497835 60497836 60550316 60561121 60569927 60575715 60620326 60620327 60711137 60714143 60735637 60757038 60819450 60853602 60863982 61004026 61064849 61071418 61104683 61109127 61120958 61158616 61164106 61175270 61190330 61303207 61425887 61453384 61516664 61538686 61607673 61657614 60129672 60140389 60152323 60152962 60179286 60201124 60208616 60279633 60288489 60338428 60358117 60367533 60387524 60422606 60438312 60461506 60461508 60497837 60505963 60505964 60537303 60550317 60569928 60575716 60615937 60653330 60690737 60714144 60735638 60819460 60857995 60863983 60863986 60979593 61041738 61071419 61104684 61120960 61138172 61143243 61147777 61175271 61178947 61211621 61221429 61263171 61286467 61303220 61425889 61453385 61512408 61516671 61560199 61607674 61621137 61746795 62262050 60095055 60117033 60135208 60145195 60152963 60155332 60186866 60201126 60208618 60265706 60279635 60309129 60323292 60338429 60358118 60380444 60399608 60450636 60461510 60461512 60497838 60513225 60538407 60569930 60602433 60602434 60602436 60620329 60653331 60690738 60714145 60735639 60757039 60819463 60863990 60863991 60966631 60979602 61066607 61066609 61079805 61138177 61147780 61158619 61175272 61178937 61190325 61215268 61242315 61258932 61280070 61425890 61453386 61535655 61560201 61564737 61657627 61746796 61746797 60095056 60117035 60135209 60145196 60152325 60155333 60179287 60208620 60253764 60279636 60309132 60358119 60367535 60452041 60461515 60461517 60497839 60513226 60531965 60531967 60569931 60569932 60602440 60615940 60620332 60653332 60674158 60714146 60757040 60819459 60863994 60876915 61024662 61030979 61071420 61133156 61140187 61175273 61178941 61211622 61263173 61280076 61504077 61535665 61560202 61564738 61657628 62262051 60135210 60145197 60152964 60165625 60201127 60208622 60253765 60323294 60358120 60461521 60497840 60513227 60531969 60531971 60550318 60569934 60575717 60602443 60615929 60630479 60653333 60690739 60714147 60735640 60757041 60807998 60807999 60863997 61031021 61079806 61084120 61104685 61133157 61153533 61211623 61221430 61421223 61504078 61535666 61564739 61729527 61746798 60123299 60165626 60208624 60265707 60451180 60461527 60513228 60550319 60569941 60575718 60602445 60653336 60690740 60714148 60757042 60819247 60864001 60864002 61133158 61153534 61175274 61178935 61190324 61530434 61542635 61657630 60142916
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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