FDA Device recall Z-2594-2017
VERSA-FX II STD TUBE 130DX16H, 130DX18H, 130DX20H, 135DX16H, 135DX18H, 135DX20H, 140DX16H, 140DX18H, 140DX20H, 145DX16H, 145DX18H, 145DX20H…
- FDA Device
- Class II
- terminated
- Published 2017-06-21
On 2017-06-21 the FDA classified a Class II recall of VERSA-FX II STD TUBE 130DX16H, 130DX18H, 130DX20H, 135DX16H, 135DX18H, 135DX20H, 140DX16H, 140DX18H, 140DX20H, 145DX16H, 145DX18H, 145DX20H… 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-2594-2017 |
| 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-FX II STD TUBE 130DX16H, 130DX18H, 130DX20H, 135DX16H, 135DX18H, 135DX20H, 140DX16H, 140DX18H, 140DX20H, 145DX16H, 145DX18H, 145DX20H, 150DX16H, 150DX18H, 150DX20H
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 | 510K:K150818,K954555 Item Numbers: 00119313016 00119313018 00119313020 00119313516 00119313518 00119313520 001…510K:K150818,K954555 Item Numbers: 00119313016 00119313018 00119313020 00119313516 00119313518 00119313520 00119314016 00119314018 00119314020 00119314516 00119314518 00119314520 00119315016 00119315018 00119315020 Lot Numbers: 60528430 60528430R 367587 368766 368965 369002 368935 61067765 61067765R 61020321 61020321R 369009 61086830 61140159 61151192 61163286 61163286R 61151212 61246966 61244915 61314528 61314528R 61309346 61326723 61326723R 369454 61309347 61309347R 369477 369477R 61352928 61352928R 369558 369837 369823 61625238 61776782 37107690 45003072 37213895 37214379 62388915 62311351 62511283 62547278 62430175 62547305 62461668 62388917 62445943 62430159 62547286 37109076 37109075 37109077 62931598 62950756 62993953 62934787 63004526 63028872 62970952 62993347 62779484 63010741 62986294 62993353 63197443 |
|---|
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-2594-2017%22
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