TIBIAL I/M NAIL 15MMDX26CM — Class II medical device recall Z-2597-2017
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-2597-2017 |
|---|---|
| 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 | 1,499 |
| Reason classes | sterility |
| Lot numbers | 367894, 367894R, 368105, 368105R, 368235, 368235R, 368327, 368327R, 368330, 368330R, 368331, 368394, 368394R, 368395, 368395R, 368403, 368403R, 368409, 368409R, 368410, 368415, 368415R, 368421, 368422, 368422R, 368428, 368429, 368433, 368434, 368437, 368438, 368439, 368439R, 368440, 368440R, 368441, 368441R, 368442, 368442R, 369093 and 218 more |
| Model numbers | 00225326015, 00225328015, 00225330015, 00225332014, 00225332015, 00225334014, 00225334015, 00225336014, 00225336015, 00225338014, 00225338015, 00225340013, 00225340014, 00225340015, 00225342013, 00225342014, 00225342015, 00225344011, 00225344013, 00225344014, 00225346011, 00225346012, 00225346013 |
Product
TIBIAL I/M NAIL 15MMDX26CM, TIBIAL I/M NAIL 15MMDX28CM TIBIAL I/M NAIL 15MMDX30CM TIBIAL I/M NAIL 14MMDX32CM TIBIAL I/M NAIL 15MMDX32CM TIBIAL I/M NAIL 14MMDX34CM TIBIAL I/M NAIL 15MMDX34CM TIBIAL I/M NAIL 14MMDX36CM TIBIAL I/M NAIL 15MMDX36CM TIBIAL I/M NAIL 14MMDX38CM TIBIAL I/M NAIL 15MMDX38CM TIBIAL I/M NAIL 13MMDX40CM TIBIAL I/M NAIL 14MMDX40CM TIBIAL I/M NAIL 15MMDX40CM TIBIAL I/M NAIL 13MMDX42CM TIBIAL I/M NAIL 14MMDX42CM TIBIAL I/M NAIL 15MMDX42CM TIBIAL I/M NAIL 11MMDX44CM TIBIAL I/M NAIL 13MMDX44CM TIBIAL I/M NAIL 14MMDX44CM TIBIAL I/M NAIL 11MMDX46CM TIBIAL I/M NAIL 12MMDX46CM TIBIAL I/M NAIL 13MMDX46CM
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-2597-2017. 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.