HERBERT BONE SCREW, 3.0MM and HERBERT CANNULATED BONE S
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
- 60117014 60126278 60155287 60178897 60208414 60240381 60265317 60469641 60667003 60757014 60818325 60868434 60877876 60953936 61057493 61083223 61144260 61382948 61428496 61434453 60123231 60145083 60172484 60210898 60235186 60240382 60318917 60367391 60451947 60491785 60589767 60665682 60665683 60757015 60810891 60926378 60930484 60953937 60953938 61045584 61109124 61135014 61144262 61428498 61437196 60096548 60109535 60111962 60126279 60132072 60135124 60142531 60152397 60165150 60169711 60196507 60208415 60218735 60235187 60244038 60247673 60291570 60303879 60308478 60308479 60323219 60429155 60435646 60451952 60472779 60487172 60491786 60501138 60501139 60603149 60629958 60652968 60665904 60714756 60714757 60735916 60757016 60810892 60818328 60953942 61008526 61012463 61012464 61012465 61012466 61045586 61045587 61045588 61144264 61428502 61437198 61490670 61754462 60096549 60101706 60109537 60112829 60123232 60126280 60132073 60140244 60141574 60152398 60155288 60172485 60190827 60194301 60195422 60222272 60231258 60247674 60257483 60257484 60270650 60274974 60279001 60291572 60291574 60323220 60336408 60343703 60429156 60435650 60451953 60472780 60491790 60501140 60501141 60529889 60544298 60557791 60589768 60652972 60671883 60683409 60714758 60735917 60810894 60810895 60818329 60818330 60818331 60944477 60990430 61001693 61045590 61045591 61045592 61080404 61083225 61117670 61135015 61144266 61273769 61357130 61374874 61382949 61382950 61434454 61473777 61523647 369406 60096550 60101707 60109539 60112830 60117016 60126281 60130233 60132074 60140245 60141576 60148204 60152399 60155289 60162144 60169712 60172486 60178898 60189031 60190828 60194302 60195425 60228106 60235188 60244039 60247675 60253689 60257485 60270651 60274975 60279002 60291576 60291577 60303880 60308480 60323221 60336409 60343704 60372743 60380525 60425090 60429157 60435653 60451954 60472781 60478986 60501142 60501143 60529890 60544299 60544301 60557795 60652974 60667006 60675136 60677483 60677485 60683412 60757018 60810896 60810897 60810898 60818422 60818432 60818433 60818436 60973690 61001694 61012468 61012469 61012471 61045593 61060985 61071292 61071293 61112939 61112941 61117671 61120678 61135016 61372549 61374875 61382951 61434455 61465684 61473778 61490671 61523648 61729781 60096551 60101708 60105518 60112833 60123233 60126282 60130235 60132075 60135125 60139609 60141578 60142532 60148219 60152401 60162145 60167101 60172487 60178899 60185147 60189032 60190829 60194303 60195426 60218736 60228107 60244040 60247677 60253691 60257486 60265318 60270652 60274976 60279003 60291578 60291580 60308482 60308483 60308484 60323222 60336410 60338194 60343707 60372744 60380527 60425091 60435656 60451955 60472782 60478987 60514756 60514762 60529891 60537023 60544306 60557798 60589771 60652975 60652987 60671884 60677486 60683413 60735918 60757019 60810901 60810903 60818439 60818440 60818444 60818445 60962899 61001695 61001696 61008024 61008026 61008289 61008528 61008529 61083226 61111266 61112942 61129854 61144267 61156090 61166262 61245936 61270324 61374876 61380168 61382952 61396162 61473779 61490673 61523649 61707786 61827155 62319566 60096552 60101709 60105520 60117018 60123234 60126283 60130238 60135126 60140246 60141579 60145084 60152402 60154144 60162146 60167102 60167103 60172488 60178901 60190830 60194304 60208416 60208418 60210899 60215602 60215603 60244041 60247224 60247678 60257487 60257488 60270653 60274977 60279005 60291581 60291582 60323223 60336411 60338198 60343711 60343714 60380528 60406055 60425092 60429159 60435659 60435661 60435662 60451956 60455019 60
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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