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U.S. Department of Health and Human Services

Class 2 Device Recall VERSYS HIP SYSTEM BEADED HIP PROSTHESIS

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  Class 2 Device Recall VERSYS HIP SYSTEM BEADED HIP PROSTHESIS see related information
Date Initiated by Firm January 11, 2016
Date Posted February 22, 2016
Recall Status1 Terminated 3 on May 23, 2017
Recall Number Z-0848-2016
Recall Event ID 73142
510(K)Number K973714  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
Product VERSYS 6 INCH BEADED FC 1
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."
Code Information Item numbers: 00-7843-011-26 00-7843-011-56 00-7843-012-26 00-7843-012-56 00-7843-013-26 00-7843-013-56 00-7843-014-26 00-7843-014-56 00-7843-015-26 00-7843-015-46 00-7843-015-56 00-7843-016-26 00-7843-016-46 00-7843-016-56 00-7843-017-26 00-7843-017-46 00-7843-017-56 00-7843-018-26 00-7843-018-46 00-7843-018-56 00-7843-019-26 00-7843-019-46 00-7843-019-56 00-7843-020-26 00-7843-020-46 00-7843-020-56 00-7843-021-26 00-7843-021-46 00-7843-021-56 00-7843-022-26 00-7843-022-46 00-7843-022-56 lot numbers: 11003828 11004140 11004141 11004945 11005429 11005666 61633498 61699577 61704382 61710259 61710265 61721708 61735803 61735804 61735807 61735808 61735811 61741803 61741804 61741807 61746866 61752732 61757179 61757188 61759235 61759263 61759264 61759265 61760620 61768678 61768681 61769239 61775245 61775247 61781979 61781993 61781994 61786857 61786859 61786862 61807096 61815089 61829365 61829366 61834825 61840229 61840235 61840236 61840240 61840243 61844742 61844743 61848234 61848238 61848248 61852817 61852823 61876837 61879443 61879446 61879450 61884825 61884826 61884830 61902329 61902374 61902382 61910047 61910048 61910049 61910050 61910051 61910057 61910058 61915343 61915348 61920858 61920859 61920860 61932609 61932610 61932611 61937670 61937671 61937679 61937680 61946016 61946017 61946018 61946026 61956713 61956714 61956724 61963719 61963728 61974966 61993630 62003641 62003642 62003643 62003719 62006778 62011971 62025498 62025499 62025503 62025504 62025509 62029069 62034134 62043097 62043107 62045160 62053687 62053689 62053692 62054926 62054928 62067444 62067446 62071763 62071764 62077676 62077680 62077681 62085290 62085291 62085293 62085296 62089502 62089504 62089509 62097215 62097232 62097258 62097289 62097296 62102129 62107875 62107877 62107878 62116476 62116532 62132186 62132187 62133140 62135309 62135311 62135317 62135322 62143764 62143773 62147263 62147267 62153941 62153947 62158853 77000593 77000594 77000595 77000596 77000597 77000598 77000990 77001428 77001429 77001431 77001433 77001543 77001550 
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact Consumer Relations Call Center
800-447-5633
Manufacturer Reason
for Recall		 LDPE bag containing the implant adheres to the highly polished implant surface.
FDA Determined
Cause 2		 Process control
Action Zimmer Biomet sent an Urgent Medical Device Recall dated January 11, 2016, to all affected customers via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers with questions or concerns were instructed to contact customer service at 1-800-348-2759 or contact their Zimmer Biomet Sales Representative. For questions regarding this recall call 800-447-5633.
Quantity in Commerce 1305
Distribution 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LPH and Original Applicant = ZIMMER, INC.
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