Recall Z-0840-2016
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
CR Flex GSF Porous Femoral LPS Flex GSF Porous Femoral LPS Flex Porous Femoral prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer various sizes This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. " The CR-Flex GSF and LPS-Flex GSF uncoated (Option) and precoat styles are intended for cemented use only. " The CR-Flex GSF and LPS-Flex GSF porous coated femoral components may be used cemented or uncemented (biological fixation). " Specific uses with CR-Flex GSF or LPS-Flex GSF femorals: Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. The CR-Flex GSF femoral, when used with 90-prefix NexGen CR articular surfaces, 00-prefix 10, 12 or 14 mm or 90-prefix 17 or 20 mm Prolong Highly Crosslinked Polyethylene CR articular surfaces, or with Gender Solutions Natural-Knee Flex Congruent articular surfaces, is designed for use with a functional posterior cruciate ligament and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees. The LPS-Flex GSF femoral, when used with LPS-Flex articular surfaces, is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 155 degrees."
Codes / lots: Item numbers: 00-5752-013-01 00-5752-013-02 00-5752-013-05 00-5752-013-06 00-5752-014-01 00-5752-014-02 00-5752-014-05 00-5752-014-06 00-5752-015-01 00-5752-015-02 00-5752-015-05 00-5752-015-06 00-5752-016-01 00-5752-016-02 00-5752-016-05 00-5752-016-06 00-5752-017-01 00-5752-017-02 00-5752-017-05 00-5752-017-06 00-5762-013-51 00-5762-013-52 00-5762-014-51 00-5762-014-52 00-5762-015-51 00-5762-015-52 00-5762-016-51 00-5762-016-52 00-5762-017-51 00-5762-017-52 00-5962-012-51 00-5962-012-52 00-5962-013-51 00-5962-013-52 00-5962-014-51 00-5962-014-52 00-5962-015-51 00-5962-015-52 00-5962-016-51 00-5962-016-52 00-5962-017-51 00-5962-017-52 00-5962-018-51 00-5962-018-52 Lot numbers: 11003002 11003328 11003397 11003526 11003606 11003637 11003639 11003667 11003972 11004037 11004739 11004835 11004913 11004915 11005025 11005124 11005180 11005183 11005286 11005287 11005288 11005389 11005454 11005613 11005669 11005756 11005843 11005917 11006049 11006065 11006143 11006207 11006225 11006244 11006412 11006591 11006650 11006688 11006696 11006700 11006733 11006807 11006834 11007020 11007021 11007087 11007099 11007174 11007191 11007205 11007274 11007372 11007386 11007388 11007411 11007457…
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-0840-2016
- Initiated
- January 11, 2016
- Posted by FDA
- February 22, 2016
- Terminated
- May 23, 2017
- Product code
- MBH – Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- Quantity
- 18482
- 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-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 |
| 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 |