FDA Device recall Z-1035-2018
LPS OPTION FEMORAL C-L LPS OPTION FEMORAL C-R LPS OPTION FEMORAL D-L LPS OPTION FEMORAL D-R LPS OPTION FEMORAL E-L LPS OPTION FEMORAL E-R L…
- FDA Device
- Class II
- terminated
- Published 2018-03-21
On 2018-03-21 the FDA classified a Class II recall of LPS OPTION FEMORAL C-L LPS OPTION FEMORAL C-R LPS OPTION FEMORAL D-L LPS OPTION FEMORAL D-R LPS OPTION FEMORAL E-L LPS OPTION FEMORAL E-R L… by Zimmer Biomet, citing the LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant af….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1035-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-11-29 |
| Published | 2018-03-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | US |
Product
LPS OPTION FEMORAL C-L LPS OPTION FEMORAL C-R LPS OPTION FEMORAL D-L LPS OPTION FEMORAL D-R LPS OPTION FEMORAL E-L LPS OPTION FEMORAL E-R LPS OPTION FEMORAL F-L LPS OPTION FEMORAL F-R LPS OPTION FEMORAL G-L LPS OPTION FEMORAL G-R LPS OPTION FEMORAL H-L This device is indicated for patients with severe knee pain and disability
Reason
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
Identifiers
| code_info | 00-5996-013-01 61782577 00-5996-013-01 61863954 00-5996-013-01 61924457 00-5996-013-01 61977562 00-5996-013-01 6197…00-5996-013-01 61782577 00-5996-013-01 61863954 00-5996-013-01 61924457 00-5996-013-01 61977562 00-5996-013-01 61977561 00-5996-013-01 62003777 00-5996-013-01 62003778 00-5996-013-01 62008974 00-5996-013-01 62008972 00-5996-013-01 62051204 00-5996-013-01 62091551 00-5996-013-01 62100471 00-5996-013-01 62107986 00-5996-013-01 62107987 00-5996-013-01 62118558 00-5996-013-01 62124601 00-5996-013-01 62134289 00-5996-013-01 62151257 00-5996-013-01 62161217 00-5996-013-01 62170068 00-5996-013-01 62172687 00-5996-013-02 61782578 00-5996-013-02 61850932 00-5996-013-02 61864885 00-5996-013-02 11400172 00-5996-013-02 61922268 00-5996-013-02 61924458 00-5996-013-02 61974046 00-5996-013-02 61974131 00-5996-013-02 61974132 00-5996-013-02 61974133 00-5996-013-02 61977563 00-5996-013-02 61978530 00-5996-013-02 61989687 00-5996-013-02 61990926 00-5996-013-02 62003779 00-5996-013-02 62004852 00-5996-013-02 62009310 00-5996-013-02 62009311 00-5996-013-02 62080341 |
|---|
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-1035-2018%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.