Item codes starting with 001930 LAG SCR 12.7D X 55MM SHOR up to 155 MM, LAG SCR 12.7D X 55 MM SHO up to 100MM, LAG SCR 12.7D X 55MM STAN up to 155 MM, LAG SCR 15.8D X 55MM LARG up to 155 MM
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
- 61484349 62124275 62157179 61077209 61337135 61484350 60555611 60747379 60874833 61142854 61142854R 60325552 60293083 60879683 61284330 61286943 60085527 60436025 60513856 60879684 61284331 61286947 60145167 60186855 60210921 60815940 60879685 60152929 60293084 60483144 60523344 60483145 60523345 60483145R 60440756 60483146 60523346 61142856 60483147 60523347 60536820 60483148 60523350 60483149 60523353 60483150 60523355 60536821 60483151 60483152 60523360 60483153 60523364 60483154 60523365 61067755 60483155 60523369 60132504 60165597 60206470 60293086 60387521 60452004 60488952 60572992 60653075 60671959 60812149 60984699 61004201 61040107 61092997 61099399 61104820 61142860 61224794 61283207 60127012 60140321 60152930 60208488 60265677 60281409 60293087 60323242 60425131 60452005 60488953 60523371 60561146 60653078 60671960 60812150 60848590 61002194 61002195 61026422 61026423 61026424 61083094 61092998 61099402 61142861 61144218 61195105 61195106 61002194R 61002195R 60096566 60118985 60127013 60137590 60165601 60172576 60234054 60254715 60264345 60317521 60385457 60393375 60436028 60483156 60488954 60513859 60538635 60572993 60576792 60585224 60621346 60653083 60671961 60714813 60736759 60848591 60848592 60973703 61004197 61004199 61083095 61092999 61099403 61142862 61144219 61195108 61275457 61616168 61737706 61774929 62116937 60127013R 60106616 60112849 60127014 60132507 60137591 60140322 60145168 60150159 60165604 60172578 60181949 60195046 60234055 60254716 60258448 60258449 60281411 60281412 60293088 60293089 60317522 60319984 60329109 60425132 60430657 60448001 60452006 60528727 60538637 60572994 60585225 60621347 60653085 60653088 60671962 60671963 60702010 60736760 60794263 60830601 60848593 60848594 60970191 60970192 60970193 61026416 61026417 61026418 61037609 61037611 61099405 61117601 61133098 61136511 61142863 61142864 61195109 61224796 61224797 61224798 61296709 61296710 61562050 61578287 61616170 61737707 61774932 62116938 60106617 60132509 60135161 60137592 60145169 60150161 60159613 60172579 60175630 60181950 60185158 60195047 60208489 60242275 60245531 60249740 60254717 60258450 60281413 60281414 60281415 60293090 60293091 60317523 60319985 60329111 60338353 60338354 60342154 60344023 60406106 60448002 60452007 60452008 60523375 60528729 60538638 60550137 60572995 60585226 60612818 60653095 60653098 60653100 60671964 60671965 60702011 60714814 60736761 60782054 60812151 60830602 60848595 60848596 60879687 60970194 60970195 61004191 61004192 61004193 61037621 61040109 61040110 61040111 61069134 61077215 61099407 61104822 61104823 61128194 61133110 61136512 61136514 61142866 61209058 61224799 61224801 61224802 61224803 61256752 61286949 61344678 61420618 61453204 61473804 61546143 61562051 61562052 61616171 61629788 61686789 61737708 61737709 61774940 61982443 62124277 62124278 60159613R 60714814R 60096568 60101358 60103446 60106618 60109515 60115148 60118986 60127018 60130184 60132511 60135162 60137593 60137594 60145170 60148169 60150162 60155297 60157578 60159614 60165606 60172581 60175631 60181951 60185159 60195048 60195054 60208490 60234056 60242277 60242278 60242279 60245532 60249741 60254718 60258451 60258452 60260176 60271179 60272607 60281416 60281418 60293093 60293094 60309941 60309942 60317524 60319986 60329112 60329113 60332476 60333601 60338355 60338356 60342155 60344024 60345905 60372728 60382493 60382494 60401257 60406107 60436029 60436030 60448003 60452009 60452010 60488955 60513864 60513866 60513869 60528730 60536823 60538639 60550138 60561149 60572996 60576794 60585227 60585228 60597788 60612821 606
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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