FDA Device recall Z-1058-2018
CR-FLEX GSF PCT SZ C-R MINUS¿ CR-FLEX GSF PCT SZ D-L MINUS¿ CR-FLEX GSF PCT SZ D-R MINUS¿ CR-FLEX GSF PCT SZ E-L MINUS¿ CR-FLEX GSF PCT SZ…
- FDA Device
- Class II
- terminated
- Published 2018-03-21
On 2018-03-21 the FDA classified a Class II recall of CR-FLEX GSF PCT SZ C-R MINUS¿ CR-FLEX GSF PCT SZ D-L MINUS¿ CR-FLEX GSF PCT SZ D-R MINUS¿ CR-FLEX GSF PCT SZ E-L MINUS¿ CR-FLEX GSF PCT SZ… 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-1058-2018 |
| 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 GSF PCT SZ C-R MINUS¿ CR-FLEX GSF PCT SZ D-L MINUS¿ CR-FLEX GSF PCT SZ D-R MINUS¿ CR-FLEX GSF PCT SZ E-L MINUS¿ CR-FLEX GSF PCT SZ E-R MINUS¿¿ CR-FLEX GSF PCT SZ F-L MINUS¿ CR-FLEX GSF PCT SZ F-R MINUS¿ CR-FLEX GSF PCT SZ G-L MINUS¿ CR-FLEX GSF PCT SZ G-R MINUS¿ " These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. - Revision of previous arthroplasty procedures. " These devices are indicated for cemented use only. " The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.
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 | 00-5750-013-01 00-5750-013-02 00-5750-013-06 00-5750-014-01 00-5750-014-02 00-5750-014-05 00-5750-014-06 00-5750…00-5750-013-01 00-5750-013-02 00-5750-013-06 00-5750-014-01 00-5750-014-02 00-5750-014-05 00-5750-014-06 00-5750-015-01 00-5750-015-02 00-5750-015-05 00-5750-015-06 00-5750-016-01 00-5750-016-02 00-5750-016-05 00-5750-016-06 00-5750-017-01 00-5750-017-02 00-5750-013-01 61951107 00-5750-013-01 61990633 00-5750-013-01 62003770 00-5750-013-01 62088332 00-5750-013-01 62168463 00-5750-013-02 61970680 00-5750-013-02 62004806 00-5750-013-02 62093265 00-5750-013-02 62166656 00-5750-013-06 62120693 00-5750-014-01 61827938 00-5750-014-01 11400140 00-5750-014-01 61844939 00-5750-014-01 61879304 00-5750-014-01 11400196 00-5750-014-01 61905173 00-5750-014-01 61929402 00-5750-014-01 61951674 00-5750-014-01 61964632 00-5750-014-01 61972167 00-5750-014-01 62004808 00-5750-014-01 62029480 00-5750-014-01 62072208 00-5750-014-01 62087759 00-5750-014-01 62093268 00-5750-014-01 62121194 00-5750-014-01 62134274 00-5750-014-01 62159864 00-5750-014-01 62170341 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-1058-2018%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.