FDAFDA · Food and drugs·Recall number Z-0844-2016
CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented various sizes "The CPT Hip System is indicated for cemented use in: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur. Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis. Patients suffering from disability due to previous fusion. Patients with previously failed endoprostheses and/or total hip components in the affected extremity. Patients with acute femoral neck fractures."
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: 00-8114-000-00 00-8114-000-10 00-8114-001-00 00-8114-001-10 00-8114-002-00 00-8114-002-10 00-8114-002-18 00-8114-002-30 00-8114-003-00 00-8114-003-10 00-8114-003-18 00-8114-003-30 00-8114-004-00 00-8114-004-10 00-8114-004-20 00-8114-004-23 00-8114-004-26 00-8114-004-30 00-8114-005-00 00-8114-005-10 00-8114-005-30 00-8114-012-18 00-8114-013-18 Lot numbers: 61744462 61744471 61767815 61770620 61774067 61774069 61774070 61774071 61778347 61778352 61779345 61783709 61783710 61783712 61783713 61783715 61783716 61783717 61787012 61787026 61787032 61787033 61787039 61790491 61790493 61790501 61790503 61794997 61794998 61794999 61795001 61795002 61798096 61798097 61801163 61801166 61801167 61801169 61801170 61801172 61801173 61801175 61803852 61803853 61803854 61803855 61803856 61803857 61806780 61806781 61806783 61806784 61806785 61806786 61806795 61809116 61809117 61809118 61809119 61809120 61809121 61812094 61812095 61812096 61812097 61812098 61812101 61812102 61812502 61813926 61813927 61813928 61813929 61813930 61814507 61815827 61815828 61815829 61815830 61815831 61817968 61817970 61817972 61817973 61818534 61818535 61820815 61820816 61822313 61822314 61822317 61824704 61824705 61824706 61824707 61824708 61824709 61824710 61824711 61827848 61827849 61829560 61829562 61829563 61829564 61833280 61833301 61833302 61833303 61833304 61833305 61833306 61833307 61837744 61837745 61840597 61840598 61840599 61840601 61840602 61841627 61841628 61841629 61841630 61841631 61844297 61844298 61846959 61846960 61846961 61846962 61846963 61846964 61846965 61846966 61846967 61846968 61851867 61851868 61851869 61853681 61855217 61855219 61855220 61856107 61856108 61859387 61859950 61860466 61860468 61860469 61862656 61863697 61863702 61863704 61863740 61864107 61864108 61868120 61868121 61868122 61868140 61868141 61868226 61868227 61868228 61868229 61872550 61873644 61873645 61873646 61873647 61873648 61873649 61878460 61878461 61878462 61878463 61878464 61878465 61878466 61881183 61881184 61881185 61881186 61881187 61881188 61882605 61882606 61884446 61884447 61884448 61884449 61884450 61884451 61885889 61885891 61885893 61885894 61885895 61885896 61885897 61886881 61886882 61886883 61886884 61886886 61886888 61886890 61891284 61891285 61891286 61891287 61891350 61895488 61895489 61895490 61896747 61896748 61896750 61896751 61896752 61899081 61899082 61899188 61900816 61901482 61901483 61901484 61901486 61901591 61901592 61901593 61907674 61907675 61907676 61907677 61907678 61907679 61907680 61911438 61911439 61911440 61911441 61914809 61914810 61914812 61914813 61914814 61914815 61914816 61917998 61917999 61918001 61918002 61918003 61921687 61921688 61925024 61926447 61926448 61927037 61928454 61928455 61928456 61928457 61928458 61928459 61928460 61928461 61928462 61928463 61930411 61930412 61930413 61930414 61930415 61930416 61930417 61930418 61930419 61930420 61930446 61932567 61938086 61938087 61942508 61942512 61942515 61942518 61943379 61943380 61943381 61943382 61943383 61943384 61943385 61943618 61945114 61945115 61945116 61945117 61947147 61947698 61947699 61947702 61947709 61947710 61947735 61952548 61952549 61952550 61952551 61952552 61952553 61955182 61955183 61955184 61955185 61955186 61955187 61955188 61955189 61955191 61955193 61955194 61955195 61955608 61955609 61955610 61955611 61957399 61957401 61957402 61957403 61957404 61957405 61957406 61957407 61957408 61957409 61957410 61957411 61957412 61957413 61957414 61957415 61964621 61964622 61964624 61964625 61964626 61964627 61964628 61964629 61964630 61964631 61964634 61964635 61964636 619
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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