VERSA-FXII SC TUBE PLT 90DX16H — Class II medical device recall Z-2593-2017
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-2593-2017 |
|---|---|
| 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 | 445 |
| Reason classes | sterility |
| Lot numbers | 368893, 368898, 368898R, 368899, 368916, 368917, 370907, 371034, 37109081, 37109128, 37214354, 37214360, 37214361, 60699481, 60699481R, 60746132, 60746132R, 60812398, 60812398R, 60820576, 60844072, 60844072R, 60868450, 61577082, 61895937, 61895939, 61989416, 62279718, 62351559, 62445941, 62445942, 62511278, 62539606, 62930529, 62931489, 62931529, 63009490, 63079560, 63564928, 63594628 |
| Model numbers | 00119309016, 00119309516, 00119309518, 00119309520, 00119309522 |
Product
VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H
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-2593-2017. 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.