FDA Device recall Z-1056-2018
LPS-FLEX GSF OPT SZ C-L¿ LPS-FLEX GSF OPT SZ C-R¿ LPS-FLEX GSF OPT SZ D-L¿ LPS-FLEX GSF OPT SZ D-R¿ LPS-FLEX GSF OPT SZ E-L¿ LPS-FLEX GSF O…
- FDA Device
- Class II
- terminated
- Published 2018-03-21
On 2018-03-21 the FDA classified a Class II recall of LPS-FLEX GSF OPT SZ C-L¿ LPS-FLEX GSF OPT SZ C-R¿ LPS-FLEX GSF OPT SZ D-L¿ LPS-FLEX GSF OPT SZ D-R¿ LPS-FLEX GSF OPT SZ E-L¿ LPS-FLEX GSF O… 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-1056-2018 |
| 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 GSF OPT SZ C-L¿ LPS-FLEX GSF OPT SZ C-R¿ LPS-FLEX GSF OPT SZ D-L¿ LPS-FLEX GSF OPT SZ D-R¿ LPS-FLEX GSF OPT SZ E-L¿ LPS-FLEX GSF OPT SZ E-R¿ LPS-FLEX GSK OPT SZ F-L¿ LPS-FLEX GSF OPT SZ F-R¿ LPS-FLEX GSF OPT SZ G-L¿ LPS-FLEX GSF OPT SZ G-R¿
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 | 00-5764-013-51 61874481 00-5764-013-51 61892716 00-5764-013-51 61946510 00-5764-013-51 61954552 00-5764-013-51 6197…00-5764-013-51 61874481 00-5764-013-51 61892716 00-5764-013-51 61946510 00-5764-013-51 61954552 00-5764-013-51 61977566 00-5764-013-51 62003780 00-5764-013-51 62022335 00-5764-013-51 62029870 00-5764-013-51 62107937 00-5764-013-51 62121782 00-5764-013-51 62155687 00-5764-013-51 62159335 00-5764-013-52 61800630 00-5764-013-52 61808793 00-5764-013-52 61819071 00-5764-013-52 61885786 00-5764-013-52 61892717 00-5764-013-52 61914463 00-5764-013-52 61949724 00-5764-013-52 61954981 00-5764-013-52 61977567 00-5764-013-52 62003781 00-5764-013-52 62023325 00-5764-013-52 62030453 00-5764-013-52 62096017 00-5764-013-52 62102077 00-5764-013-52 62127093 00-5764-013-52 62137523 00-5764-013-52 62168360 00-5764-013-52 62169039 00-5764-013-52 62172720 00-5764-013-52 62172721 00-5764-013-52 62173154 00-5764-014-51 61793522 00-5764-014-51 61796450 00-5764-014-51 61802094 00-5764-014-51 61816554 00-5764-014-51 61817772 00-5764-014-51 61817773 00-5764-014-51 11400112 |
|---|
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-1056-2018%22
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