NKII CSTI Porous Femoral NKII NP Femoral prosthesis — Class II medical device recall Z-0839-2016
Terminated recall by Zimmer Biomet, Inc., reported 2016-03-02, distributed nationwide. LDPE bag containing the implant adheres to the highly polished implant surface.
| Recall number | Z-0839-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2016-01-11 |
| Classified | 2016-02-22 |
| Reported by FDA | 2016-03-02 |
| Terminated | 2017-05-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BB, BE, BM, BO, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, ES, FR, GB, GT, HK, HN, HR, IL, IN, IT, JM, JP, KR, MX, MY, NI, NZ, PA, PE, SE, SG, SV, TH, TW, VE |
| Quantity | 13,483 |
| 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 and 460 more |
| Model 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 and 2 more |
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."
Reason for recall
LDPE bag containing the implant adheres to the highly polished implant surface.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0839-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.