Recall Z-0846-2016
Zimmer Biomet, Inc. · initiated January 11, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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."
Codes / lots: 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
Reason for recall
LDPE bag containing the implant adheres to the highly polished implant surface.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-0846-2016
- Initiated
- January 11, 2016
- Posted by FDA
- February 22, 2016
- Terminated
- May 23, 2017
- Product code
- LPH – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Quantity
- 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…
- Recalling firm
- Zimmer Biomet, Inc., Warsaw, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0830-2016 Class II | LPS-FLEX GSF OPT prosthesis, knee, patellofemorotibial, semi-constrained, cemented…LDPE bag containing the implant adheres to the highly polished implant surface. | 01/11/2016Terminated |
| Z-0831-2016 Class II | NexGen CR-FLEX Option FEM NexGen CR-FLEX Precoat FEM NexGen CR-FLEX Porous FEM…LDPE bag containing the implant adheres to the highly polished implant surface. | 01/11/2016Terminated |
| Z-0832-2016 Class II | NexGen LPS-FLEX Option Femoral NexGen LPS-FLEX Precoat Femoral prosthesis, knee…LDPE bag containing the implant adheres to the highly polished implant surface. | 01/11/2016Terminated |
| Z-0833-2016 Class II | NexGen Knee CR Porous FEM NexGen Knee CR Precoat FEM prosthesis, knee…LDPE bag containing the implant adheres to the highly polished implant surface. | 01/11/2016Terminated |
| Z-0834-2016 Class II | NexGen Knee LPS Porous FEM NexGen Knee LPS Option FEM NexGen Knee Lock FEM prosthesis…LDPE bag containing the implant adheres to the highly polished implant surface. | 01/11/2016Terminated |
| Z-0835-2016 Class II | NexGen Knee CR Option Fem NexGen Knee CR Porous Fem NexGen Knee CR Precoat Fem NexGen…LDPE bag containing the implant adheres to the highly polished implant surface. | 01/11/2016Terminated |
| Z-0836-2016 Class II | ZIMMER UNI HIGH FLEX PRECOAT FEM prosthesis, knee, femorotibial, non-constrained…LDPE bag containing the implant adheres to the highly polished implant surface. | 01/11/2016Terminated |
| Z-0837-2016 Class II | Gender PFJ FEMORAL COMP, prosthesis, knee, patello/femorotibial, semi-constrained…LDPE bag containing the implant adheres to the highly polished implant surface. | 01/11/2016Terminated |
| Z-0838-2016 Class II | CR Flex GSF Precoat Fem Natural Knee GSF NP Flex Natural Knee GSF POR Flex Natural Knee…LDPE bag containing the implant adheres to the highly polished implant surface. | 01/11/2016Terminated |
| Z-0839-2016 Class II | NKII CSTI Porous Femoral NKII NP Femoral prosthesis, knee, patellofemorotibial…LDPE bag containing the implant adheres to the highly polished implant surface. | 01/11/2016Terminated |
| Z-0840-2016 Class II | CR Flex GSF Porous Femoral LPS Flex GSF Porous Femoral LPS Flex Porous Femoral…LDPE bag containing the implant adheres to the highly polished implant surface. | 01/11/2016Terminated |
| Z-0841-2016 Class II | NexGen LPS Flex Option Femoral NexGen LPS Flex Precoat Femoral prosthesis, knee…LDPE bag containing the implant adheres to the highly polished implant surface. | 01/11/2016Terminated |
| Z-0842-2016 Class II | PRCT MIS CR MOB PLT prosthesis, knee, patellofemorotibial, semi-constrained…LDPE bag containing the implant adheres to the highly polished implant surface. | 01/11/2016Terminated |
| Z-0843-2016 Class II | CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented…LDPE bag containing the implant adheres to the highly polished implant surface. | 01/11/2016Terminated |
| Z-0844-2016 Class II | CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented…LDPE bag containing the implant adheres to the highly polished implant surface. | 01/11/2016Terminated |
| Z-0845-2016 Class II | Bipolar Shell prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or…LDPE bag containing the implant adheres to the highly polished implant surface. | 01/11/2016Terminated |
| Z-0847-2016 Class II | VERSYS 7.5 INCH BEADED FC prosthesis, hip, semi-constrained, metal/polymer, porous…LDPE bag containing the implant adheres to the highly polished implant surface. | 01/11/2016Terminated |
| Z-0848-2016 Class II | VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, porous…LDPE bag containing the implant adheres to the highly polished implant surface. | 01/11/2016Terminated |
| Z-0849-2016 Class II | VERSYS 6 INCH BEADED FC 1 VERSYS 6 INCH BEADED FC S VERSYS 8 INCH BEADED FC 1 VERSYS 8…LDPE bag containing the implant adheres to the highly polished implant surface. | 01/11/2016Terminated |
| Z-0850-2016 Class II | Metasul Head 40, 12/14, SZ M/0 total hip prosthesis - metal femoral heads…LDPE bag containing the implant adheres to the highly polished implant surface. | 01/11/2016Terminated |