MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENEST, THOMPSON HIP PROSTHESIS 3, 4, 5 and 6.
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
- 60484301 60536380 60565715 60753818 60817438 60864746 61003323 61059514 61081364 61121949 61135827 61387138 61783644 365466 60096346 60097010 60259990 60422473 60459752 60515365 60674982 60715057 60768520 60787821 60799626 60799627 61012710 61029791 61029797 61075345 61103552 61103553 61121950 61121951 61135828 61883369 61901575 61938344 369678 369843 60242811 60260004 60317143 60370104 60411929 60411932 60441611 60501819 60501820 60501821 60540465 60553615 60715059 60759283 60759284 60759285 60787991 60799628 60979642 61003325 61012729 61059519 61121952 61121954 61222215 61339786 61398793 61528632 61541580 61565702 61589080 61613237 61921999 61938346 60085561 60096349 60097011 60124640 60134157 60148294 60154764 60154765 60169374 60169375 60187551 60187552 60242814 60260197 60274423 60301862 60313429 60335338 60395245 60395246 60422533 60442559 60484312 60501825 60511856 60553618 60574472 60600313 60609939 60753835 60768538 60768539 60768541 60768542 60787295 60799629 60799630 60990033 61003326 61003327 61012713 61029792 61042227 61059521 61059540 61059541 61121955 61121958 61286077 61293836 61336916 61356578 61365617 61427119 61506293 61550873 61567517 61685104 61708167 61744439 61803839 61846938 61886948 61987166 365462 366297 367557 370033 60091185 60110058 60110136 60110138 60124644 60124646 60134158 60134159 60141863 60148295 60166638 60169376 60169383 60204468 60242818 60242819 60242820 60260206 60274450 60274453 60274486 60293234 60293235 60293236 60293237 60313507 60326529 60395249 60395250 60411943 60411944 60422535 60441625 60459776 60484317 60501827 60523550 60552243 60552244 60565799 60574476 60574477 60574478 60609942 60609943 60646735 60700464 60700465 60743733 60743734 60768553 60787311 60787313 60842140 60900070 60919566 61003328 61029793 61029794 61033867 61033868 61075309 61103522 61103523 61103525 61121959 61166175 61183999 61197657 61218568 61218569 61356579 61365618 61369497 61435961 61468751 61484505 61490076 61541589 61550869 61565703 61579856 61651260 61658293 61736305 61806778 61812090 61832976 61843323 61868575 61899073 61911421 61922002 61943374 61999753 365434 367541 60093205 60099414 60110153 60110154 60110156 60124815 60124816 60124817 60124818 60134160 60134161 60134162 60141864 60154806 60154807 60154808 60154809 60166765 60169391 60169392 60187557 60187558 60187561 60204503 60204505 60242826 60242827 60242828 60260214 60260215 60260216 60274535 60274537 60274538 60293272 60301870 60301879 60313514 60317111 60326535 60326536 60335396 60335398 60335399 60335501 60355069 60370156 60395256 60411951 60411952 60422537 60441686 60441687 60459782 60484351 60501906 60506708 60532115 60553758 60565844 60574481 60600321 60609949 60609951 60609952 60700473 60720006 60727912 60727913 60743737 60757942 60768559 60768560 60768562 60768563 60768564 60787902 60787903 60799631 60799632 60808890 60817439 60829549 60842142 60919567 60979643 61023526 61027849 61029796 61045164 61045165 61059522 61075346 61109415 61121960 61121961 61121962 61121963 61121964 61135833 61205903 61207319 61266251 61282906 61293827 61293830 61318404 61329738 61336918 61339791 61365609 61365610 61381009 61398794 61401529 61427120 61453527 61468750 61472280 61472281 61509857 61522982 61534386 61541602 61562536 61599943 61601327 61613239 61631083 61688425 61708172 61727052 61750634 61779334 61806760 61830025 61866243 61907705 61911422 61938348 61952543 61957373 365440 367558 60089773 60089774 60110160 60110161 60110162 60124825 60134163 60134164 60148325 60154858 60154871 60169410 60187563 60204691 60204694 60204710 60204711 60204712 60204713 60
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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