VERSA-FX II KEYLESS TUBE, VERSA-FX II KEYLESS SHORT, VERSA-FX II SHORT TUBE PL, VERSA-FX II STD TUBE PLAT and VERSA-FX II SUPRACONDYLR Item codes starting with 0011930, 0011931 and 0011941
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
- 366026 60252546 60386429 60387234 60387236 60664570 60746113 60820564 368890 60131310 60161887 60208595 60337755 60386430 60387237 60674436 60674437 60746114 60820565 62063880 60674437R 366027 60165190 60351204 60406618 60598293 60699479 60714970 60820566 61753280 366028 368891 60189692 60510769 60699480 60714938 60820568 60189692R 366029 368892 60154515 60413139 60740818 60812406 62161712 366030 60844072 60868450 60844072R 368894 60154516 60173867 60175580 60206848 60292114 60366271 60379893 60424741 60452501 60476633 60523009 60523011 60568292 60598291 60598292 60610993 60619081 60646238 60726314 60746117 60911330 60931155 60944509 61076064 61169404 61505367 61523575 61640872 62098503 60082818 60082819 60119113 60129285 60144960 60147708 60175581 60182119 60241838 60278773 60328084 60410030 60435440 60476635 60510770 60539704 60581931 60619076 60664573 60726313 60763191 60787023 60877481 60890087 60890088 60900735 60911331 60928243 60931156 60932380 60938399 60943332 60944510 61140151 61163257 61264711 61294823 61374274 61505374 61505375 61558652 61590985 61640873 61748725 62045196 62063886 368896 60127957 60129286 60156372 60189693 60215781 60252548 60292116 60353487 60383970 60405451 60452504 60502812 60539715 60539717 60568287 60581933 60619073 60646239 60726315 60726316 60726317 60726318 60890089 60911332 60918552 61114103 61120930 61344223 61505376 61558653 61596975 61602061 61677240 62050758 62057618 366505 60129287 60175582 60260273 60410031 60433745 60482396 60510771 60619078 60726319 60763195 60959966 61031789 61128189 61527193 61558654 61602062 61748726 61753014 62045197 368373 369962 60402976 60424743 60445069 60510772 60619079 60968719 61118961 61198403 61264715 61693779 62045195 62063881 368898 370907 60812398 61577082 62279718 00368898R 60165193 60482973 60527776 60533011 368916 60598295 60746132 60820576 60598295R 60746132R 60699481 61895937 60074372R 60699481R 368960 60136494 60189695 60266339 60353489 60370812 60383972 60416018 60473692 60489349 60510773 60548437 60699482 60746134 60746137 60803571 60820577 60959967 60962101 61041079 61076065 61118962 61140152 61341979 61503009 61529227 61596976 61780109 366037 368961 60115491 60129288 60136496 60165202 60202542 60231320 60270737 60278775 60325673 60337763 60353490 60359553 60360711 60383974 60393527 60405454 60420022 60452508 60473693 60510507 60568294 60598296 60628437 60630043 60664579 60699483 60746151 60746152 60803572 60803573 60897286 60911333 60932382 60943333 60972786 60998281 61027493 61041080 61076066 61114104 61118963 61140153 61151189 61198406 61264716 61286854 61341980 61375159 61499393 61509877 61523576 61538708 61565471 61621778 61640874 61677268 61677278 61748727 61748729 60998281R 370385 60118087 60119115 60129289 60129290 60136497 60154517 60156373 60165205 60165206 60165207 60189696 60208598 60215782 60215784 60252550 60252551 60269204 60269207 60278777 60325674 60337769 60353491 60366275 60383975 60383976 60387238 60393528 60405455 60420024 60435441 60445071 60452511 60473694 60476637 60485409 60489351 60510508 60510509 60533026 60548395 60568303 60572660 60598297 60610994 60619085 60629728 60629729 60630044 60664586 60664589 60746153 60787024 60803574 60803575 60845769 60845770 60868454 60868456 60874078 60877482 60911334 60918557 60938403 60959968 60962102 60998282 61011698 61027495 61041081 61086812 61109156 61114105 61140154 61151190 61163260 61198407 61198408 61264717 61294824 61375160 61499395 61499396 61499397 61509878 61511594 61516746 61538709 61565472 61621780 61640875 61677279 61677280 61677281 61693783 62330816 60129289R 60845770R
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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