Recall Z-0839-2016
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
NKII CSTI Porous Femoral NKII NP Femoral prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer variou sizes Product Usage "" The Natural-Knee II System with Cancellous-Structured Titanium (CSTi) Porous Coating is 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). " The Natural-Knee II primary components without CSTi Porous Coating, all posterior stabilized and revision components, the N-K II Constrained Knee System, the modular cemented tibial baseplate, and the revision stem and revision fluted stem are indicated for cemented use only in skeletally mature individuals with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD), correctable valgus-varus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists. When the primary or N-K II Constrained Knee System components are used, the medial and collateral ligaments must be intact. " The Natural-Knee II Durasul polyethylene components are indicated for patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory degenerative joint disease (IJD), e.g., rheumatoid arthritis; correctable valgus-varus deformity and moderate flexion contracture; those patients with failed previous surgery where pain, deformity, or dysfunction persists; and revision of previously failed knee arthroplasty. These devices are intended for cemented use only in the United States."
Codes / lots: Item numbers: 6212-00-007 6212-00-008 6212-00-009 6212-00-010 6212-00-011 6212-00-020 6212-00-021 6212-00-030 6212-00-031 6212-00-040 6212-00-041 6212-00-050 6212-00-051 6307-00-006 6307-00-007 6307-00-008 6307-00-009 6307-00-010 6307-00-011 6307-00-020 6307-00-021 6307-00-030 6307-00-031 6307-00-040 6307-00-041 6307-00-050 6307-00-051 Lot numbers: 11002695 11003148 11003157 11003159 11003165 11003167 11003170 11003181 11003190 11003192 11003193 11003195 11003196 11003201 11003212 11003214 11003216 11003223 11003228 11003230 11003231 11003232 11003235 11003236 11003240 11003241 11003244 11003248 11003249 11003251 11003252 11003253 11003255 11003257 11003258 11003259 11003261 11003267 11003981 11004011 11004072 11004206 11004207 11004208 11004247 11004248 11004286 11004310 11004330 11004367 11004383 11004384 11004385 11004386 11004410 11004411 11004426 11004427 11004473 11004475 11004541 11004550 11004551 11004588 11004589 11004590 11004592 11004593 11004603 11004604 11004610 11004636 11004637 11004644 11004664 11004783 11004784 11004785 11004800 11004802 11004803 11004839 11004841 11004844 11004846 11004876 11004879 11004937 11004938 11004939 11004940 11004960 11004967 11004968…
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-0839-2016
- 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
- 13483
- 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-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 |