R-F IM NAIL 10MMDX48CM LG — Class II medical device recall Z-2595-2017
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-2595-2017 |
|---|---|
| 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 | 3,856 |
| Reason classes | sterility |
| Lot numbers | 367186, 367186R, 367189, 367189R, 367809, 367809R, 367810, 367810R, 367829, 367829R, 367869, 367869R, 367871, 368143, 368148, 368149, 368150, 368294, 368294R, 368297, 368298, 368298R, 368299, 368299R, 368301, 368301R, 368302, 368302R, 368305, 368306, 368306R, 368307, 368309, 368309R, 368310, 368310R, 368340, 368340R, 368517, 368530 and 257 more |
| Model numbers | 00224001048, 00224001142, 00224001144, 00224001146, 00224001148, 00224001246, 00224001248, 00224001340, 00224001342, 00224001344, 00224001346, 00224001348, 00224001434, 00224001436, 00224001438, 00224001440, 00224001442, 00224001444, 00224001446, 00224001448 |
Product
R-F IM NAIL 10MMDX48CM LG, 11MMDX42CM, 11MMDX44CM, 11MMDX46CM LG, 11MMDX48CM LG, 12MMDX46CM LG, 12MMDX48CM LG, 13MMDX40CM, 13MMDX42CM, 13MMDX44CM, 13MMDX46CM LG, 13MMDX48CM LG, 14MMDX34CM, 14MMDX36CM, 14MMDX38CM, 14MMDX40CM, 14MMDX42CM, 14MMDX44CM, 14MMDX46CM LG, 14MMDX48CM LG
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-2595-2017. 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.