FDA Device recall Z-2595-2017
R-F IM NAIL 10MMDX48CM LG, 11MMDX42CM, 11MMDX44CM, 11MMDX46CM LG, 11MMDX48CM LG, 12MMDX46CM LG, 12MMDX48CM LG, 13MMDX40CM, 13MMDX42CM, 13MM…
- FDA Device
- Class II
- terminated
- Published 2017-06-21
On 2017-06-21 the FDA classified a Class II recall of R-F IM NAIL 10MMDX48CM LG, 11MMDX42CM, 11MMDX44CM, 11MMDX46CM LG, 11MMDX48CM LG, 12MMDX46CM LG, 12MMDX48CM LG, 13MMDX40CM, 13MMDX42CM, 13MM… 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-2595-2017 |
| 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
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
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: K965098,K142281,K962561 Item Numbers: 00224001048 00224001142 00224001144 00224001146 00224001148 0022400…510K: K965098,K142281,K962561 Item Numbers: 00224001048 00224001142 00224001144 00224001146 00224001148 00224001246 00224001248 00224001340 00224001342 00224001344 00224001346 00224001348 00224001434 00224001436 00224001438 00224001440 00224001442 00224001444 00224001446 00224001448 Lot Numbers: 60677568 60684983 60677568R 60684983R 60670026 60670026R 60645750 60645750R 60691655 60691655R 60711471 60711471R 60715081 60715081R 60725139 60725139R 60754804 60754804R 60747476 60747462 60747462R 60747477 60815078 60815079 60816181 60815078R 60815079R 60816181R 60816180 60816180R 60820253 367186 367189 60822094 367186R 367189R 60822094R 367810 367810R 60839006 60837666 60844163 60844196 60837666R 60844163R 60844196R 367869 367871 367869R 60848701 60854080 60848701R 60854080R 60854079 60854079R 367829 367829R 60859062 368307 368310 60859063 368310R 60859063R 368299 368302 368299R 368302R 368148 368143 |
|---|
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-2595-2017%22
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