FDA Device recall Z-2593-2017
VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H
- FDA Device
- Class II
- terminated
- Published 2017-06-21
On 2017-06-21 the FDA classified a Class II recall of VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H by Zimmer Biomet, citing zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2593-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-28 |
| Published | 2017-06-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
Product
VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H
Reason
Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures.
Identifiers
| code_info | I10K: K954555,K150818 Item Numbers: 00119309016, 00119309516, 00119309518, 00119309520, 00119309522; Lot Numbers: 60…I10K: K954555,K150818 Item Numbers: 00119309016, 00119309516, 00119309518, 00119309520, 00119309522; Lot Numbers: 60746132 60746132R 60699481 60699481R 60812398 60812398R 60844072 60844072R 60820576 60868450 368893 368898 368898R 368917 368916 368899 61577082 61989416 370907 61895937 61895939 371034 62279718 62351559 62445941 62445942 62511278 62539606 37214360 37214354 37214361 37109128 37109081 62931489 62931529 62930529 63009490 63079560 63564928 63594628 |
|---|
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-2593-2017%22
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