FDAFDA · Food and drugs·Recall number Z-0849-2016
VERSYS 6 INCH BEADED FC 1 VERSYS 6 INCH BEADED FC S VERSYS 8 INCH BEADED FC 1 VERSYS 8 INCH BEADED FC 2 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures. " Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected."
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: 00-7843-011-06 00-7843-011-08 00-7843-011-36 00-7843-012-06 00-7843-012-08 00-7843-012-36 00-7843-013-06 00-7843-013-08 00-7843-013-36 00-7843-014-06 00-7843-014-08 00-7843-014-36 00-7843-015-06 00-7843-015-08 00-7843-015-36 00-7843-016-06 00-7843-016-08 00-7843-016-36 00-7843-017-06 00-7843-017-08 00-7843-017-36 00-7843-018-06 00-7843-018-08 00-7843-018-36 00-7843-019-06 00-7843-019-36 00-7843-020-06 00-7843-020-08 00-7843-020-36 00-7843-021-06 00-7843-021-36 00-7843-022-06 00-7843-022-36 Lot numbers: 11003968 11003975 11004089 11004219 11004274 11004333 11004746 11005067 11005118 11008034 61669552 61669554 61669559 61669561 61669563 61695978 61699465 61704396 61704397 61714436 61721717 61721719 61721720 61729915 61729916 61729917 61729919 61735802 61735816 61735817 61735818 61741801 61741802 61741815 61746858 61746859 61746860 61746875 61746876 61746878 61746888 61746890 61746892 61752717 61752718 61752719 61752722 61752738 61752739 61752740 61759256 61759257 61759271 61759272 61759273 61759274 61759275 61759276 61768675 61768676 61768677 61768689 61768690 61768691 61768692 61768693 61768695 61768696 61768697 61768698 61768699 61775242 61775243 61775251 61775252 61775253 61775254 61781978 61781998 61781999 61782001 61782002 61786858 61786866 61786867 61792530 61792544 61792545 61792546 61792547 61792561 61797304 61797305 61797306 61797307 61797308 61797309 61797310 61797311 61797312 61797314 61797315 61797316 61797317 61797318 61797319 61797320 61797321 61797322 61797323 61803226 61803227 61803229 61803230 61803231 61803233 61807094 61807095 61807106 61807107 61807108 61807109 61807110 61807111 61807112 61807113 61807114 61813331 61813332 61813336 61813345 61813352 61813353 61813356 61813363 61813364 61813367 61813369 61813370 61813371 61813372 61813373 61813374 61814011 61814012 61814013 61814014 61814015 61814016 61814017 61814018 61814019 61814020 61814021 61814022 61814023 61815074 61815075 61815077 61815078 61815096 61815098 61829335 61829338 61829339 61829341 61829343 61829349 61829351 61829370 61829371 61829372 61829374 61829375 61834813 61834815 61834822 61834823 61834824 61834827 61834830 61834831 61840205 61840209 61840221 61840224 61840227 61840232 61840233 61840234 61840238 61840242 61840251 61840252 61844728 61844729 61844730 61844731 61844732 61844733 61844734 61844738 61844739 61844740 61844744 61848231 61848232 61848233 61848235 61848237 61848240 61848241 61848242 61848244 61848245 61848246 61848247 61848250 61848251 61852807 61852808 61852809 61852812 61852813 61852814 61852815 61852816 61852819 61852822 61852825 61852826 61852827 61852828 61872116 61872117 61872118 61872120 61872122 61872123 61872126 61876835 61876836 61876839 61876840 61876842 61876843 61876844 61876845 61876847 61876848 61876858 61879445 61879447 61879449 61879451 61879461 61886029 61886030 61886032 61886033 61886039 61886045 61886047 61890372 61890373 61890374 61890375 61890376 61890377 61890378 61890379 61890380 61890383 61894503 61894505 61894508 61894510 61894511 61894514 61902381 61910054 61915336 61915337 61915338 61915339 61915340 61915341 61915344 61915346 61917982 61920851 61920852 61920853 61920854 61920855 61920856 61920861 61920864 61920908 61920909 61925413 61925414 61925417 61925419 61925421 61925422 61925424 61925425 61925426 61925427 61925428 61925429 61925435 61932606 61932607 61932608 61932612 61932613 61937666 61937667 61937668 61937674 61937675 61937677 61941398 61941399 61941400 61941401 61941402 61941403 61941405 61941406 61941407 61946013 61946015 61946019 61946020 61946021 61946022 61946023 61946024 61951267 61951268 61951269 619
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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