FDA Device recall Z-0835-2016
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 prost…
- FDA Device
- Class II
- terminated
- Published 2016-03-02
On 2016-03-02 the FDA classified a Class II recall of 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 prost… by Zimmer Biomet, citing LDPE bag containing the implant adheres to the highly polished implant surface.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0835-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-11 |
| Published | 2016-03-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | US |
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
LDPE bag containing the implant adheres to the highly polished implant surface.
Identifiers
| code_info | Item 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-…Item 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 00-5970-015-04 00-5970-016-01 00-5970-016-02 00-5970-017-01 00-5970-017-02 00-5970-018-01 00-5970-018-02 00-5972-011-01 00-5972-011-02 00-5972-012-01 00-5972-012-02 00-5972-013-01 00-5972-013-02 00-5972-013-03 00-5972-013-04 00-5972-014-01 00-5972-014-02 00-5972-014-03 00-5972-014-04 00-5972-015-01 00-5972-015-02 00-5972-015-03 00-5972-015-04 00-5972-016-01 00-5972-016-02 00-5972-017-01 00-5972-017-02 00-5972-018-01 00-5972-018-02 00-5990-011-01 00-5990-011-02 00-5990-011-31 00-5990-011-32 00-5990-012-01 00-5990-012-02 00-5990-012-31 00-5990-0 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0835-2016%22
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