| Class 2 Device Recall VERSYS HIP SYSTEM BEADED MIDCOAT LOW HEAD CENTER HIP PROSTHESIS, MODEL 007840XXXXX | |
Date Initiated by Firm | January 11, 2016 |
Date Posted | February 22, 2016 |
Recall Status1 |
Terminated 3 on May 23, 2017 |
Recall Number | Z-0846-2016 |
Recall Event ID |
73142 |
510(K)Number | K042776 |
Product Classification |
Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
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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: 00-7843-011-16 00-7843-012-16 00-7843-013-16 00-7843-014-16 00-7843-015-16 00-7843-016-16 Lot numbers: 61760685 61781980 61840199 61844725 61844726 61951281 61956725 61968111 61987956 62011958 62029062 62034145 62097248 62097288 62120672 |
Recalling Firm/ Manufacturer |
Zimmer Biomet, Inc. 1800 W Center St Warsaw IN 46580-2304
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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 | 130 |
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 |
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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.
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510(K) Database | 510(K)s with Product Code = LPH
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