FDA Device recall Z-1042-2018
CR OPTION FEM COMP SIZE C/L CR OPTION FEM COMP SIZE C/R CR OPTION FEM COMP SIZE D/L CR OPTION FEM COMP SIZE D/R CR OPTION FEM COMP SIZE E/L…
- FDA Device
- Class II
- terminated
- Published 2018-03-21
On 2018-03-21 the FDA classified a Class II recall of CR OPTION FEM COMP SIZE C/L CR OPTION FEM COMP SIZE C/R CR OPTION FEM COMP SIZE D/L CR OPTION FEM COMP SIZE D/R CR OPTION FEM COMP SIZE E/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-1042-2018 |
| 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
CR OPTION FEM COMP SIZE C/L CR OPTION FEM COMP SIZE C/R CR OPTION FEM COMP SIZE D/L CR OPTION FEM COMP SIZE D/R CR OPTION FEM COMP SIZE E/L CR OPTION FEM COMP SIZE E/R CR OPTION FEM COMP SIZE F/L CR OPTION FEM COMP SIZE F/R CR OPTION FEM COMP SIZE G/L CR OPTION FEM COMP SIZE 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 | 00-5966-013-01 61893236 00-5966-013-01 61939720 00-5966-013-01 61976414 00-5966-013-01 61997338 00-5966-013-01 6199…00-5966-013-01 61893236 00-5966-013-01 61939720 00-5966-013-01 61976414 00-5966-013-01 61997338 00-5966-013-01 61997339 00-5966-013-01 62164866 00-5966-013-01 62173181 00-5966-013-02 61893622 00-5966-013-02 61939721 00-5966-013-02 61976415 00-5966-013-02 61997340 00-5966-013-02 61998618 00-5966-013-02 62142586 00-5966-013-02 62172419 00-5966-014-01 61782655 00-5966-014-01 61850922 00-5966-014-01 61855960 00-5966-014-01 61873439 00-5966-014-01 61883263 00-5966-014-01 61883264 00-5966-014-01 61886303 00-5966-014-01 61890020 00-5966-014-01 61890021 00-5966-014-01 61890694 00-5966-014-01 61896063 00-5966-014-01 61916149 00-5966-014-01 61918723 00-5966-014-01 61918967 00-5966-014-01 61924446 00-5966-014-01 61933809 00-5966-014-01 61943608 00-5966-014-01 61946984 00-5966-014-01 11400307 00-5966-014-01 61971724 00-5966-014-01 61971725 00-5966-014-01 61974122 00-5966-014-01 61974123 00-5966-014-01 61978521 00-5966-014-01 61978522 00-5966-014-01 61989037 |
|---|
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-1042-2018%22
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