VERSA-FX II STD TUBE 130DX16H — Class II medical device recall Z-2594-2017
Terminated recall by Zimmer Biomet, Inc., reported 2017-06-21, distributed in AK, AL, AR, AZ, CA, CO, CT, FL…. Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configur
| Recall number | Z-2594-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2017-04-28 |
| Classified | 2017-06-15 |
| Reported by FDA | 2017-06-21 |
| Terminated | 2019-05-15 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, 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 |
| Countries outside the US | AE, AR, AU, BE, BR, CA, CH, CN, DE, DZ, EG, ES, FR, GB, GT, HN, IN, IT, JM, JO, JP, KR, LB, MA, MX, MY, NI, NL, NZ, PA, PE, PL, SA, SG, SV, TH, TW |
| Quantity | 510 |
| Reason classes | sterility |
| Lot numbers | 367587, 368766, 368935, 368965, 369002, 369009, 369454, 369477, 369477R, 369558, 369823, 369837, 37107690, 37109075, 37109076, 37109077, 37213895, 37214379, 45003072, 60528430, 60528430R, 61020321, 61020321R, 61067765, 61067765R, 61086830, 61140159, 61151192, 61151212, 61163286, 61163286R, 61244915, 61246966, 61309346, 61309347, 61309347R, 61314528, 61314528R, 61326723, 61326723R and 28 more |
| Model numbers | 00119313016, 00119313018, 00119313020, 00119313516, 00119313518, 00119313520, 00119314016, 00119314018, 00119314020, 00119314516, 00119314518, 00119314520, 00119315016, 00119315018, 00119315020 |
Product
VERSA-FX II STD TUBE 130DX16H, 130DX18H, 130DX20H, 135DX16H, 135DX18H, 135DX20H, 140DX16H, 140DX18H, 140DX20H, 145DX16H, 145DX18H, 145DX20H, 150DX16H, 150DX18H, 150DX20H
Reason for recall
Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2594-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.