Recall Z-0850-2016
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
Metasul Head 40, 12/14, SZ M/0 total hip prosthesis - metal femoral heads Noninflammatory degenerative joint disease (NIDJD) including avascular necrosis, osteoarthritis, post-traumatic arthritis and congenital hip dysplasia and inflammatory joint disease (IJD) e.g. rheumatoid arthritis if bone quality is adequate. Failed previous surgery where pain, deformity, or dysfunction persists. Revision of previously failed hip arthroplasty. Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. This includes severely handicapped patients with multiple joint involvement, for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives. The system is intended for use either with or without bone cement in total hip arthroplasty."
Codes / lots: Item number: 00-8770-040-02 Lots: 2564467 2573371 2625382 2631721 2655075 2655076 2685143
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-0850-2016
- Initiated
- January 11, 2016
- Posted by FDA
- February 22, 2016
- Terminated
- May 23, 2017
- Product code
- KWA – Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
- Quantity
- 194
- 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-0846-2016 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-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 |