FDA Device recall Z-1043-2018
LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-R LPS-FLEX OPTION FEMORAL D-L LPS-FLEX OPTION FEMORAL D-R…
- FDA Device
- Class II
- terminated
- Published 2018-03-21
On 2018-03-21 the FDA classified a Class II recall of LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-R LPS-FLEX OPTION FEMORAL D-L LPS-FLEX OPTION FEMORAL D-R… 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-1043-2018 |
| 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-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-R LPS-FLEX OPTION FEMORAL D-L LPS-FLEX OPTION FEMORAL D-R LPS-FLEX OPTION FEMORAL E-L LPS-FLEX OPTION FEMORAL E-R LPS-FLEX OPTION FEMORAL F-L LPS-FLEX OPTION FEMORAL F-R LPS-FLEX OPTION FEMORAL G-L LPS-FLEX OPTION FEMORAL G-R 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 | 00-5964-014-51 62171767 00-5964-014-52 61804723 00-5964-014-52 61804724 00-5964-014-52 61804726 00-5964-014-52 6180…00-5964-014-51 62171767 00-5964-014-52 61804723 00-5964-014-52 61804724 00-5964-014-52 61804726 00-5964-014-52 61804725 00-5964-014-52 61811767 00-5964-014-52 61811768 00-5964-014-52 61812820 00-5964-014-52 61814746 00-5964-014-52 61814749 00-5964-014-52 61814750 00-5964-014-52 61814747 00-5964-014-52 61814751 00-5964-014-52 61815695 00-5964-014-52 61829046 00-5964-014-52 61832272 00-5964-014-52 61832273 00-5964-014-52 61832274 00-5964-014-52 61839689 00-5964-014-52 61839691 00-5964-014-52 61847653 00-5964-014-52 61847654 00-5964-014-52 61847655 00-5964-014-52 61860204 00-5964-014-52 61860203 00-5964-014-52 61860205 00-5964-014-52 61860206 00-5964-014-52 61866693 00-5964-014-52 61869843 00-5964-014-52 61870709 00-5964-014-52 61874450 00-5964-014-52 61878263 00-5964-014-52 61878262 00-5964-014-52 61883260 00-5964-014-52 61884178 00-5964-014-52 61886312 00-5964-014-52 61890007 00-5964-014-52 61890008 00-5964-014-52 61895306 00-5964-014-52 61894531 |
|---|
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-1043-2018%22
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