FDA Device recall Z-1032-2018

CR-FLEX POR HATCP FEM C-L CR-FLEX POR HATCP FEM C-R CR-FLEX POR HATCP FEM D-L CR-FLEX POR HATCP FEM D-R CR-FLEX POR HATCP FEM E-L CR-FLEX P…

FDA Device
Class II
terminated
Published 2018-03-21

On 2018-03-21 the FDA classified a Class II recall of CR-FLEX POR HATCP FEM C-L CR-FLEX POR HATCP FEM C-R CR-FLEX POR HATCP FEM D-L CR-FLEX POR HATCP FEM D-R CR-FLEX POR HATCP FEM E-L CR-FLEX P… 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-1032-2018
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-FLEX POR HATCP FEM C-L CR-FLEX POR HATCP FEM C-R CR-FLEX POR HATCP FEM D-L CR-FLEX POR HATCP FEM D-R CR-FLEX POR HATCP FEM E-L CR-FLEX POR HATCP FEM E-R CR-FLEX POR HATCP FEM F-L CR-FLEX POR HATCP FEM F-R CR-FLEX POR HATCP FEM G-L CR-FLEX POR HATCP FEM 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	65-5952-013-01 62020175 65-5952-013-02 62038825 65-5952-013-02 62110571 65-5952-014-01 61782590 65-5952-014-01 6181… 65-5952-013-01 62020175 65-5952-013-02 62038825 65-5952-013-02 62110571 65-5952-014-01 61782590 65-5952-014-01 61815515 65-5952-014-01 61846120 65-5952-014-01 61855468 65-5952-014-01 61866624 65-5952-014-01 11004583 65-5952-014-01 61987911 65-5952-014-01 62020176 65-5952-014-01 62046099 65-5952-014-01 62068159 65-5952-014-01 62117121 65-5952-014-02 61822350 65-5952-014-02 61848475 65-5952-014-02 61899497 65-5952-014-02 61974938 65-5952-014-02 62013405 65-5952-014-02 62032575 65-5952-014-02 62068160 65-5952-014-02 62110572 65-5952-014-02 62139310 65-5952-015-01 61801431 65-5952-015-01 61822351 65-5952-015-01 61831562 65-5952-015-01 61855469 65-5952-015-01 61861694 65-5952-015-01 11004349 65-5952-015-01 11004533 65-5952-015-01 61910510 65-5952-015-01 61949553 65-5952-015-01 61936668 65-5952-015-01 61994913 65-5952-015-01 11005729 65-5952-015-01 62005727 65-5952-015-01 62025668 65-5952-015-01 62025669 65-5952-015-01 11006459 65-5952-015-01 62054539

code_info

65-5952-013-01 62020175 65-5952-013-02 62038825 65-5952-013-02 62110571 65-5952-014-01 61782590 65-5952-014-01 6181…

65-5952-013-01 62020175 65-5952-013-02 62038825 65-5952-013-02 62110571 65-5952-014-01 61782590 65-5952-014-01 61815515 65-5952-014-01 61846120 65-5952-014-01 61855468 65-5952-014-01 61866624 65-5952-014-01 11004583 65-5952-014-01 61987911 65-5952-014-01 62020176 65-5952-014-01 62046099 65-5952-014-01 62068159 65-5952-014-01 62117121 65-5952-014-02 61822350 65-5952-014-02 61848475 65-5952-014-02 61899497 65-5952-014-02 61974938 65-5952-014-02 62013405 65-5952-014-02 62032575 65-5952-014-02 62068160 65-5952-014-02 62110572 65-5952-014-02 62139310 65-5952-015-01 61801431 65-5952-015-01 61822351 65-5952-015-01 61831562 65-5952-015-01 61855469 65-5952-015-01 61861694 65-5952-015-01 11004349 65-5952-015-01 11004533 65-5952-015-01 61910510 65-5952-015-01 61949553 65-5952-015-01 61936668 65-5952-015-01 61994913 65-5952-015-01 11005729 65-5952-015-01 62005727 65-5952-015-01 62025668 65-5952-015-01 62025669 65-5952-015-01 11006459 65-5952-015-01 62054539

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-1032-2018%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.