INTERLOCKING IM SCREW 4.5 and INTERLOCKING IM SCREW LG Some items starting with codes 0022530
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
- 60625043 60678699 60690742 60728338 60747676 60757045 60813551 60864020 60864021 60915935 60915936 61003973 60806395 60829584 60864023 60867711 60867767 60550320 60569951 60597681 60653347 60690746 60735651 60757047 60757048 60808005 60817585 60829586 60829587 60864037 60864038 60864040 60867771 61161394 61190864 61194691 61215177 61319429 61379510 60518291 60606752 60620346 60711145 60728343 60757050 60806397 60806398 60829592 60829594 60867782 60867785 61071422 61150075 61173568 61319435 61319436 61379514 60748952 60762088 60806399 60876899 60876901 60876902 61248174 61325065 60123303 60130220 60135214 60142918 60150073 60218846 60243102 60279663 60309141 60323311 60338439 60349093 60387528 60393392 60407659 60422612 60422615 60422617 60422618 60505967 60505968 60569960 60597683 60597684 60602462 60620369 60620371 60690750 60690751 60714161 60714162 60735662 60735663 60757051 60757052 60808010 60808011 60814567 60814568 60829596 60829597 60867787 60867788 60867789 60867790 60867792 60956540 60956547 61003994 61004003 61004006 61004010 61035979 61035980 61064854 61066610 61066611 61071425 61071426 61084123 61100815 61158640 61211625 61211626 61221436 61249859 61271267 61286461 61421225 61496669 61509881 61535667 61564743 61664934 61729550 61729552 61746802 61746803 62262065 60123304 60132558 60142920 60152971 60253769 60253770 60280195 60288490 60310563 60310564 60310565 60323343 60338521 60367544 60393393 60393395 60407661 60410614 60438323 60451198 60472688 60487155 60487156 60491717 60491718 60505969 60602464 60602465 60602466 60602467 60620387 60653365 60690752 60690753 60714165 60735665 60735666 60757057 60757058 60757059 60817613 60829604 60867807 60867809 60867811 60867813 60956553 60979622 60985458 60985459 60985460 61024754 61024757 61031015 61031016 61035968 61035972 61041707 61041709 61041713 61064855 61066614 61066615 61067796 61073739 61091734 61096524 61104693 61133860 61133862 61150093 61153543 61199894 61210272 61224276 61269415 61295067 61362462 61382019 61489978 61504080 61504081 61564747 61650565 61657650 61664935 60099580 60103529 60109578 60109579 60123308 60123309 60127535 60132562 60132563 60135218 60140394 60142924 60142925 60150077 60154195 60154196 60154197 60155336 60167149 60169750 60186875 60218855 60229996 60242017 60243123 60243124 60253778 60253779 60253780 60265723 60265724 60265725 60288499 60288501 60288502 60288503 60288504 60288505 60310578 60310582 60323351 60323352 60338534 60338537 60338539 60338540 60358127 60367556 60367560 60380468 60385469 60393402 60393403 60407668 60407669 60410616 60422634 60425160 60425161 60444819 60444820 60452048 60455028 60472693 60472694 60479134 60479135 60487157 60491724 60491725 60505973 60505974 60505975 60505976 60505977 60569969 60569970 60575726 60602498 60602499 60602501 60602502 60602504 60602505 60602506 60620394 60620395 60620396 60630485 60653377 60653381 60674212 60690760 60690761 60714182 60714183 60714184 60714186 60735674 60735676 60757069 60757070 60757072 60757073 60757074 60817603 60817604 60817605 60817607 60817608 60817609 60876980 60876984 60876985 60876987 60926474 60926475 60926476 60926478 60926479 60926480 60926481 60926482 60966586 60966587 60966588 60966590 60966591 60979628 60985467 61009884 61024666 61030980 61030983 61035951 61041617 61041618 61041698 61064857 61066619 61066621 61067798 61071429 61071440 61075712 61075713 61084125 61084126 61096534 61096536 61133873 61133877 61150110 61150112 61150114 61150116 61161408 61199901 61202928 61202931 61228843 61269436 61269439 61307114 61329372 61343035 61343037 61356918 61356922 61356926
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.