NexGen Knee CR Option Fem NexGen Knee CR Porous Fem NexGen Knee CR… — Class II medical device recall Z-0835-2016
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-0835-2016 |
|---|---|
| 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 | 32,508 |
| Lot numbers | 11002771, 11003380, 11003415, 11003450, 11003451, 11003469, 11003477, 11003574, 11003575, 11003576, 11003583, 11003586, 11003593, 11003597, 11003601, 11003602, 11003612, 11003613, 11003626, 11003643, 11003644, 11003666, 11003673, 11003825, 11003832, 11003870, 11003871, 11003889, 11003890, 11003893, 11003941, 11003942, 11003954, 11003956, 11004035, 11004043, 11004058, 11004080, 11004101, 11004189 and 460 more |
| Model numbers | 00-5966-013-01, 00-5966-013-02, 00-5966-014-01, 00-5966-014-02, 00-5966-015-01, 00-5966-015-02, 00-5966-016-01, 00-5966-016-02, 00-5966-017-01, 00-5966-017-02, 00-5970-011-01, 00-5970-011-02, 00-5970-012-01, 00-5970-012-02, 00-5970-013-01, 00-5970-013-02, 00-5970-013-03, 00-5970-013-04, 00-5970-014-01, 00-5970-014-02, 00-5970-014-03, 00-5970-014-04, 00-5970-015-01, 00-5970-015-02, 00-5970-015-03 and 91 more |
Product
NexGen Knee CR Option Fem NexGen Knee CR Porous Fem NexGen Knee CR Precoat Fem NexGen Knee LPS Porous Fem NexGen Knee LPS Precoat Fem prosthesis, knee, patellofemorotibial, semi-constrained, cemented, 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. " CR and LPS porous coated femoral and tibial baseplate components may be used cemented or uncemented (biological fixation). The CR Hydroxyapatite/tricalcium phosphate [HA/TCP] coated femoral or tibial baseplate components may only be used uncemented. All other femoral, tibial baseplate and all-polyethylene patella components are indicated for cemented use only."
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-0835-2016. 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.