FDA Device recall Z-1044-2018
LPS-FLEX PRECOAT FEMORAL B-R LPS-FLEX PRECOAT FEMORAL C-L LPS-FLEX PRECOAT FEMORAL C-R LPS-FLEX PRECOAT FEMORAL D-L LPS-FLEX PRECOAT FEMORA…
- FDA Device
- Class II
- terminated
- Published 2018-03-21
On 2018-03-21 the FDA classified a Class II recall of LPS-FLEX PRECOAT FEMORAL B-R LPS-FLEX PRECOAT FEMORAL C-L LPS-FLEX PRECOAT FEMORAL C-R LPS-FLEX PRECOAT FEMORAL D-L LPS-FLEX PRECOAT FEMORA… 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-1044-2018 |
| 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 PRECOAT FEMORAL B-R LPS-FLEX PRECOAT FEMORAL C-L LPS-FLEX PRECOAT FEMORAL C-R LPS-FLEX PRECOAT FEMORAL D-L LPS-FLEX PRECOAT FEMORAL D-R LPS-FLEX PRECOAT FEMORAL E-L LPS-FLEX PRECOAT FEMORAL E-R LPS-FLEX PRECOAT FEMORAL F-L LPS-FLEX PRECOAT FEMORAL F-R LPS-FLEX PRECOAT FEMORAL G-L LPS-FLEX PRECOAT FEMORAL G-R LPS-FLEX PRECOAT FEMORAL H-L LPS-FLEX PRECOAT FEMORAL H-R¿ LPS-FLEX POROUS FEMORAL E-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 | 00-5960-012-51 62163094 00-5960-012-52 114687 00-5960-012-52 62162221 00-5960-013-51 61418001 00-5960-013-51 110062…00-5960-012-51 62163094 00-5960-012-52 114687 00-5960-012-52 62162221 00-5960-013-51 61418001 00-5960-013-51 11006251 00-5960-013-51 62119540 00-5960-013-51 62130947 00-5960-013-51 62174403 00-5960-013-52 62120588 00-5960-013-52 62130963 00-5960-014-51 11400330 00-5960-014-51 11006176 00-5960-014-51 11006333 00-5960-014-51 62120591 00-5960-014-51 62131197 00-5960-014-51 62134257 00-5960-014-51 62170032 00-5960-014-52 62012423 00-5960-014-52 11006544 00-5960-014-52 62061891 00-5960-014-52 62121191 00-5960-014-52 62131248 00-5960-014-52 62134703 00-5960-014-52 62171835 00-5960-014-52 62174384 00-5960-015-51 62121224 00-5960-015-51 62131267 00-5960-015-51 62134706 00-5960-015-51 62168365 00-5960-015-52 61641772 00-5960-015-52 62121768 00-5960-015-52 62121770 00-5960-015-52 62131277 00-5960-015-52 62135957 00-5960-016-51 61793525 00-5960-016-51 61784879 00-5960-016-51 62121790 00-5960-016-51 62121792 00-5960-016-51 62131249 00-5960-016-51 62131284 00 |
|---|
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-1044-2018%22
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