Recall Z-0838-2016
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 Precoat Fem Natural Knee GSF NP Flex Natural Knee GSF POR Flex Natural Knee GSM NP Flex Natural Knee GSM POR Flex prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes Components with CSTi porous coating are indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD). " Components without CSTi porous coating are indicated for cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD), correctable varus-valgus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists. " The N-K Flex femoral provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. When used with N-K Flex, NexGen CR-Flex Mobile*, NexGen UC-Flex Mobile*, NexGen Trabecular Metal" CR Monoblock, 90-prefix NexGen CR, 00-prefix 10, 12 or 14mm or 90-prefix 17 or 20mm Prolong Highly Crosslinked Polyethylene CR articular surfaces, it is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees."
Codes / lots: Item numbers: 00-5410-014-01 00-5410-014-02 00-5410-015-01 00-5410-015-02 00-5410-016-01 00-5410-016-02 00-5410-017-01 00-5410-017-02 00-5410-018-01 00-5410-018-02 00-5412-014-02 00-5412-015-01 00-5412-016-02 00-5414-013-01 00-5414-014-01 00-5414-014-02 00-5414-015-01 00-5414-015-02 00-5414-016-01 00-5414-016-02 00-5416-013-01 00-5416-013-02 00-5416-014-01 00-5416-014-02 00-5416-015-01 00-5416-015-02 00-5416-016-01 00-5416-016-02 00-5416-017-01 00-5416-017-02 00-5750-013-01 00-5750-013-02 00-5750-013-05 00-5750-013-06 00-5750-014-01 00-5750-014-02 00-5750-014-05 00-5750-014-06 00-5750-015-01 00-5750-015-02 00-5750-015-05 00-5750-015-06 00-5750-016-01 00-5750-016-02 00-5750-016-05 00-5750-016-06 00-5750-017-01 00-5750-017-02 00-5750-017-05 00-5750-017-06 Lot numbers: 11001439 11002693 11003150 11003160 11003161 11003162 11003163 11003168 11003169 11003173 11003174 11003175 11003176 11003185 11003186 11003187 11003198 11003202 11003203 11003210 11003215 11003219 11003229 11003233 11003234 11003237 11003243 11003246 11003247 11003254 11003977 11004073 11004242 11004243 11004264 11004265 11004293 11004308 11004329 11004366 11004474 11004485 11004487 11004489 11004509 11004515…
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-0838-2016
- Initiated
- January 11, 2016
- Posted by FDA
- February 22, 2016
- Terminated
- May 23, 2017
- Product code
- JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Quantity
- 61485
- 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-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 |
| 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 |