MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENEST, THOMPSON HIP PROSTHESIS sizes 3, 4, 5, and 6, and Mod Austin Moore Fem Stem
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
- 60204970 60242926 60877896 61059555 60148524 60162051 60187879 61178682 365451 60097214 60097216 60313377 60395244 60441594 60484309 60540466 60609930 60768532 60979646 61003342 61029820 61135862 61307977 61575440 369866 60087317 60097220 60172931 60187880 60242928 60242933 60293228 60335340 60395248 60422523 60484314 60540516 60609935 60743728 60864758 60877921 60919578 61102981 61135863 61262147 61262148 61336941 61575443 61575444 367763 60120648 60124981 60172935 60187881 60326524 60335353 60370152 60411948 60441627 60532104 60581829 60726774 60787322 60900086 60960054 61003345 61122115 61179463 61262149 61387146 61575446 61596750 365457 366212 369774 60064812 60095554 60095560 60134404 60154918 60187882 60204978 60242941 60242942 60260213 60335392 60335393 60370158 60395262 60411955 60411956 60484366 60484367 60501914 60532123 60540536 60609996 60678493 60727909 60727910 60743735 60787899 60887298 60900087 61003347 61012722 61081371 61122116 61158989 61179459 61262150 61304671 61318408 61329737 61339783 61387149 61501412 61565711 61575452 60095693 60095694 60204979 60260220 60293281 60395267 60423089 60484383 60532144 60574503 61003348 61003349 61029828 61118583 61122119 61153010 61282911 61324219 61356603 61453524 61575460 61575462 60085706 60095713 60095714 60169604 60204981 60242974 60242975 60260221 60293303 60326540 60370208 60370209 60411976 60423093 60484384 60506722 60540820 60581932 60727952 60808903 60900088 61003350 61012732 61042240 61122120 61122121 61183998 61273012 61286073 61336942 61468754 61575468 61708166 366432 60095748 60095756 60095778 60139193 60317118 60484702 60506730 61012733 61042241 61059557 61135866 61260563 61336943 61592242 61607581 365471 366358 366990 367755 369775 60095777 60095783 60154919 60260446 60317117 60370238 60383173 60423125 60484712 60506746 60540828 60582009 60610179 60610180 60835007 60864759 61045178 61164596 61178681 61575470 61708163 365479 60081485 60095784 60095805 60412007 60484715 60553895 60727999 61012758 61036131 61122123 61339897 61592243 61696347 366276 60154920 60169605 60204984 60260471 60260472 60523637 60835008 61023524 61081372 61169379 61255862 61387154 61711961 365456 366275 367759 60095881 60148833 60423135 60610259 60728040 60835009 60979648 61122124 61282921 61619987 60095907 60187883 60335429 60506789 60665150 60728051 60787917 61199172 61336945 61708173 60095908 60293369 60808904 61135867 61336946 367614 60063230 60260630 60469795 60728059 61042242 61231911 365467 60095911 61601348 365477 60095912 365480 60095928 60933807 60095966 60095967 60370153 60459779 60990032 60233503 60335394 60553757 61582444 61783682 365491 61582445 61748929 366361 60187598 60301903 60834952 365452 60293345 60506751 61199167 61582447 366362 60095986 61501406 365495 366364 61582449 61783684 60331363 366366 365483 60532130 60845453 365455 365611 365459 60301909 60323737 60979560 60118708 60293376 366370 60096024 60096025 61711957 60096026 60335331 60345747 60395243 60741845 60787822 61427125 61453526 60278489 60335335 60459772 60726726 60768537 61003351 61447734 365490 367790 60154773 60293230 60335350 60411942 60743730 60768551 60919579 61298516 61420426 61472284 367791 60096191 60124666 60148864 60187874 60187875 60242824 60242825 60293232 60370154 60484331 60743731 60743732 60817454 61075343 61370531 61447732 61872568 367792 60110432 60154852 60169399 60187555 60242832 60293280 60317107 60335499 60370177 60411957 60484368 60532135 60720033 60768571 60787901 60945814 61042244 61075344 61298519 61341668 61447731 61783687 365493 369884 370112 60110433 60124826 60148866 60187884
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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