FREE-LOCK LAG SCREW, 12.7, FREE-LOCK LAG SCREW, 15.8, FREE-LOCK SUPRACOND TUBE and FREE-LOCK TUBE & SCP PLAT. Items starting with codes 0011810 and 0011811.
Publicado el 26 de febrero de 2014 · Inicio del retiro: 11 de octubre de 2013
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Zimmer, Inc.
- Distribuidor
- 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.
- Lote
- 60879678 61278171 61625237 60564708 61026414 60564708R 60564710 60915347 61141512 61142759 60639474 60782037 62046409 60155294 60206463 62120939 60206463R 60108502 60152927 60206464 60862361 60862362 60862361R 60142899 60165580 60206466 60487350 60671954 60736748 61491355 62120941 60208478 60815946 61278172 61502705 60142901 60172569 60281392 60538633 60705043 60736749 60830649 61026415 60162132 60639475 60781210 61110037 60782040 60782041 61345993 61399023 61045321 61400219 60817011 61268917 60782042 60931208 61400222 61400223 61393376 60782043 61141513 61278174 61284322 61026411 61286935 60106612 60572988 61286938 61491356 60071404 60099545 60107375 60218931 60218932 60653031 60782044 61026409 61195093 61420626 61502706 61616173 60080046 60109509 60115145 60126996 60154170 60195018 60208481 60234047 60275162 60472815 60536817 60653032 60781212 60879681 61026406 61141514 61195094 61274845 61284324 61345995 61629793 61700052 60111966 60112840 60123244 60126997 60142902 60165583 60175627 60189035 60190841 60218933 60218934 60222827 60222828 60234048 60275163 60281396 60290741 60293063 60323238 60653043 60701995 60705044 60782045 60812141 60862367 61037587 61037588 61141515 61195095 61209053 61251129 61278175 61284325 61420628 61466805 61614765 61663369 61278175R 60097895 60103441 60106613 60112843 60123245 60126998 60132497 60142903 60154171 60157576 60172572 60181946 60186847 60195020 60208482 60215946 60222829 60222830 60234049 60242264 60242265 60254701 60275164 60281399 60290742 60293064 60293065 60323239 60572989 60621339 60653053 60671955 60701998 60736750 60782046 60812142 60931209 61026403 61026404 61077251 61110038 61120992 61141516 61171562 61184409 61195096 61209054 61251130 61428485 61534196 61609887 61644214 61663371 61195096R 60088618 60097896 60099546 60103442 60107376 60107377 60123246 60126999 60135159 60142904 60150153 60155295 60165584 60172573 60186849 60195021 60208483 60215947 60222831 60222832 60234050 60236419 60242267 60242269 60254706 60275165 60281401 60290743 60293066 60323240 60381062 60401298 60572990 60621340 60621341 60653057 60671956 60702002 60705045 60782047 60812143 60830650 60862366 60931212 60931213 61037589 61037590 61069128 61083091 61142760 61171564 61184407 61195097 61209055 61420629 61466807 61589581 61762401 62106371 62197640 60186849R 60097897 60103444 60111967 60115146 60123247 60127001 60140305 60142905 60150155 60165585 60181947 60186850 60195022 60208485 60215948 60234051 60236421 60242270 60242271 60254707 60275166 60281404 60290744 60293067 60381063 60401299 60621342 60653063 60671957 60705046 60736752 60782048 60812144 60862369 61026401 61026402 61037586 61069129 61083092 61141517 61171565 61184408 61195098 61209056 61278176 61405652 61466808 61663373 61762403 62197642 60705046R 60097898 60106614 60109511 60112844 60123248 60127002 60135160 60150156 60165586 60181948 60186851 60195023 60222833 60222844 60234052 60264008 60281402 60290745 60323241 60452002 60513841 60536818 60550134 60621343 60653066 60671958 60714808 60782049 60812145 60931215 61037591 61063230 61063232 61069130 61083093 61142761 61195099 61251131 61275452 61284326 61379219 61420631 61466814 61609889 61663375 61762486 60106615 60112846 60123249 60142906 60154172 60175628 60206468 60254708 60264010 60452003 60550135 60653069 60702006 60781213 60830652 60931211 61026407 61069131 61142762 61195101 61286940 61405653 61428488 61663376 60123250 60142907 60186852 60218935 60218936 60234053 60275167 60621345 60714809 60973693 60973694 61077253 61179647 61184410 61195102 61466840 60137579 60208486 60680439 60705047 61026405 612
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
¿Vendes productos como este?
Recalert vigila todo tu catálogo contra retiros como este, automáticamente.