FDAFDA · Food and drugs·Recall number Z-0838-2016
CR Flex GSF Precoat Fem Natural Knee GSF NP Flex Natural Knee GSF POR Flex Natural Knee GSM NP Flex Natural Knee GSM POR Flex prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes Components with CSTi porous coating are indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD). " Components without CSTi porous coating are indicated for cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD), correctable varus-valgus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists. " The N-K Flex femoral provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. When used with N-K Flex, NexGen CR-Flex Mobile*, NexGen UC-Flex Mobile*, NexGen Trabecular Metal" CR Monoblock, 90-prefix NexGen CR, 00-prefix 10, 12 or 14mm or 90-prefix 17 or 20mm Prolong¿ Highly Crosslinked Polyethylene CR articular surfaces, it is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees."
Published March 2, 2016 · Recall initiated: January 11, 2016
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
LDPE bag containing the implant adheres to the highly polished implant surface.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer Biomet, Inc.
- Distributor
- Worldwide Distribution - US (nationwide) and Internationally to ARGENTINA AUSTRALIA AUSTRIA BARBADOS BELGIUM BERMUDA BOLIVIA BRAZIL CARIBBEAN CHILE CHINA COLOMBIA COST RICA DENMARK DOMINICAN REPUBLIC DORAL FL ECUADOR EL SALVADOR ENGLAND FRANCE GERMANY GUATEMALA HONDURAS HONG KONG INDIA ISRAEL ITALY JAMAICA JAPAN KOREA MALAYSIA MEXICO NEW ZEALAND NICARAGUA PANAMA PERU SINGAPORE SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND VENEZUELA WEST INDIES Canary Islands Croatia Cyprus Czech Republic Canada
- Lot
- Item numbers: 00-5410-014-01 00-5410-014-02 00-5410-015-01 00-5410-015-02 00-5410-016-01 00-5410-016-02 00-5410-017-01 00-5410-017-02 00-5410-018-01 00-5410-018-02 00-5412-014-02 00-5412-015-01 00-5412-016-02 00-5414-013-01 00-5414-014-01 00-5414-014-02 00-5414-015-01 00-5414-015-02 00-5414-016-01 00-5414-016-02 00-5416-013-01 00-5416-013-02 00-5416-014-01 00-5416-014-02 00-5416-015-01 00-5416-015-02 00-5416-016-01 00-5416-016-02 00-5416-017-01 00-5416-017-02 00-5750-013-01 00-5750-013-02 00-5750-013-05 00-5750-013-06 00-5750-014-01 00-5750-014-02 00-5750-014-05 00-5750-014-06 00-5750-015-01 00-5750-015-02 00-5750-015-05 00-5750-015-06 00-5750-016-01 00-5750-016-02 00-5750-016-05 00-5750-016-06 00-5750-017-01 00-5750-017-02 00-5750-017-05 00-5750-017-06 Lot numbers: 11001439 11002693 11003150 11003160 11003161 11003162 11003163 11003168 11003169 11003173 11003174 11003175 11003176 11003185 11003186 11003187 11003198 11003202 11003203 11003210 11003215 11003219 11003229 11003233 11003234 11003237 11003243 11003246 11003247 11003254 11003977 11004073 11004242 11004243 11004264 11004265 11004293 11004308 11004329 11004366 11004474 11004485 11004487 11004489 11004509 11004515 11004517 11004518 11004528 11004570 11004594 11004646 11004672 11004678 11004685 11004686 11004749 11004757 11004758 11004760 11004763 11004764 11004774 11004775 11004776 11004777 11004778 11004779 11004780 11004781 11004782 11004786 11004787 11004788 11004789 11004804 11004805 11004809 11004810 11004811 11004812 11004842 11004843 11004856 11004881 11004883 11004897 11004898 11004920 11004922 11004923 11004924 11004926 11004935 11004965 11004994 11005008 11005009 11005010 11005045 11005065 11005122 11005127 11005128 11005129 11005159 11005160 11005161 11005179 11005187 11005188 11005189 11005191 11005192 11005193 11005210 11005219 11005220 11005235 11005237 11005238 11005303 11005304 11005305 11005306 11005307 11005308 11005309 11005312 11005313 11005314 11005315 11005362 11005381 11005416 11005417 11005418 11005419 11005421 11005422 11005427 11005478 11005479 11005505 11005515 11005516 11005517 11005518 11005519 11005521 11005522 11005523 11005541 11005542 11005543 11005559 11005609 11005645 11005648 11005649 11005650 11005651 11005691 11005769 11005791 11005792 11005793 11005805 11005839 11005841 11005842 11005859 11005863 11005895 11005929 11005935 11005968 11005969 11005972 11005973 11006005 11006006 11006009 11006011 11006032 11006076 11006099 11006101 11006102 11006103 11006140 11006141 11006142 11006146 11006164 11006165 11006166 11006167 11006186 11006187 11006188 11006229 11006230 11006231 11006232 11006233 11006235 11006236 11006237 11006283 11006284 11006291 11006308 11006314 11006367 11006419 11006435 11006456 11006491 11006493 11006495 11006496 11006497 11006516 11006517 11006526 11006531 11006534 11006535 11006536 11006551 11006552 11006553 11006554 11006557 11006566 11006583 11006584 11006602 11006603 11006613 11006621 11006628 11006638 11006639 11006649 11006658 11006659 11006675 11006703 11006704 11006705 11006721 11006726 11006745 11006750 11006759 11006760 11006784 11006788 11006789 11006790 11006802 11006804 11006821 11006844 11006855 11006856 11006857 11006858 11006874 11006875 11006910 11006911 11006912 11006913 11006918 11006919 11006945 11006956 11006957 11006964 11006965 11006966 11006967 11006981 11006990 11006992 11007000 11007003 11007004 11007025 11007027 11007030 11007036 11007039 11007046 11007055 11007068 11007082 11007083 11007084 11007085 11007086 11007100 11007103 11007104 11007114 11007115 11007116 11007135 11007136 11007151 11007170 11007173 11007175 11007187
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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