FDA Device recall Z-0834-2016
NexGen Knee LPS Porous FEM NexGen Knee LPS Option FEM NexGen Knee Lock FEM prosthesis, knee, patellofemorotibial, semi-constrained, cemente…
- FDA Device
- Class II
- terminated
- Published 2016-03-02
On 2016-03-02 the FDA classified a Class II recall of NexGen Knee LPS Porous FEM NexGen Knee LPS Option FEM NexGen Knee Lock FEM prosthesis, knee, patellofemorotibial, semi-constrained, cemente… 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-0834-2016 |
| 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 LPS Porous FEM NexGen Knee LPS Option FEM NexGen Knee Lock FEM prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes Product Usage "" 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: 00-5992-017-91 00-5992-017-92 00-5994-013-01 00-5994-013-02 00-5994-013-91 00-5994-013-92 00-5994-…Item numbers: 00-5992-017-91 00-5992-017-92 00-5994-013-01 00-5994-013-02 00-5994-013-91 00-5994-013-92 00-5994-014-01 00-5994-014-02 00-5994-014-91 00-5994-014-92 00-5994-015-01 00-5994-015-02 00-5994-015-91 00-5994-015-92 00-5994-016-01 00-5994-016-02 00-5994-016-91 00-5994-016-92 00-5994-017-01 00-5994-017-02 00-5994-017-91 00-5994-017-92 00-5996-011-01 00-5996-011-02 00-5996-011-51 00-5996-011-52 00-5996-012-01 00-5996-012-02 00-5996-012-51 00-5996-012-52 00-5996-013-01 00-5996-013-02 00-5996-013-51 00-5996-013-52 00-5996-014-01 00-5996-014-02 00-5996-014-51 00-5996-014-52 00-5996-015-01 00-5996-015-02 00-5996-015-51 00-5996-015-52 00-5996-016-01 00-5996-016-02 00-5996-016-51 00-5996-016-52 00-5996-017-01 00-5996-017-02 00-5996-017-51 00-5996-017-52 00-5996-017-91 00-5996-017-92 00-5996-018-01 00-5996-018-02 00-5996-018-51 00-5996-018-52 00-5996-018-91 00-5996-018-92 Lot numbers: 11002128 11002763 11003329 11003332 1 |
|---|
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-0834-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.