FDA Device recall Z-1051-2018
PRCT MIS CR MOB PLT SZ 4 L¿ PRCT MIS CR MOB PLT SZ 5 L¿ PRCT MIS CR MOB PLT SZ 6 L¿ PRCT MIS CR MOB PLT SZ 7 L¿ PRCT MIS CR MOB PLT SZ 7 R¿…
- FDA Device
- Class II
- terminated
- Published 2018-03-21
On 2018-03-21 the FDA classified a Class II recall of PRCT MIS CR MOB PLT SZ 4 L¿ PRCT MIS CR MOB PLT SZ 5 L¿ PRCT MIS CR MOB PLT SZ 6 L¿ PRCT MIS CR MOB PLT SZ 7 L¿ PRCT MIS CR MOB PLT SZ 7 R¿… 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-1051-2018 |
| 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
PRCT MIS CR MOB PLT SZ 4 L¿ PRCT MIS CR MOB PLT SZ 5 L¿ PRCT MIS CR MOB PLT SZ 6 L¿ PRCT MIS CR MOB PLT SZ 7 L¿ PRCT MIS CR MOB PLT SZ 7 R¿ PRCT MIS CR MOB PLT SZ 8 L¿ PRCT MIS CR MOB PLT SZ 8 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 | 00-5930-040-01 61774223 00-5930-040-01 61780003 00-5930-040-01 61774226 00-5930-040-01 61774225 00-5930-040-01 1100…00-5930-040-01 61774223 00-5930-040-01 61780003 00-5930-040-01 61774226 00-5930-040-01 61774225 00-5930-040-01 11005139 00-5930-050-01 61774236 00-5930-050-01 11004031 00-5930-060-01 61774234 00-5930-070-02 61780002 00-5930-070-01 62139076 00-5930-080-02 61774216 00-5930-080-01 61774229 00-5930-080-01 61780004 00-5930-080-02 61785662 00-5930-080-02 61774215 |
|---|
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-1051-2018%22
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