RecallRadar

FDA Device recall Z-2596-2017

FEM IM NAIL 15MMDX30CM, FEM IM NAIL 16MMDX30CM FEM IM NAIL 14MMDX32CM FEM IM NAIL 15MMDX32CM FEM IM NAIL 16MMDX32CM FEM IM NAIL 14MMDX34CM…

On 2017-06-21 the FDA classified a Class II recall of FEM IM NAIL 15MMDX30CM, FEM IM NAIL 16MMDX30CM FEM IM NAIL 14MMDX32CM FEM IM NAIL 15MMDX32CM FEM IM NAIL 16MMDX32CM FEM IM NAIL 14MMDX34CM… 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

AgencyFDA Device
Recall numberZ-2596-2017
ClassificationClass II
Statusterminated
Initiated2017-04-28
Published2017-06-21
Last updated2026-09-13 11:54 UTC
CompanyZimmer Biomet
DistributionAK, 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

FEM IM NAIL 15MMDX30CM, FEM IM NAIL 16MMDX30CM FEM IM NAIL 14MMDX32CM FEM IM NAIL 15MMDX32CM FEM IM NAIL 16MMDX32CM FEM IM NAIL 14MMDX34CM FEM IM NAIL 15MMDX34CM FEM IM NAIL 16MMDX34CM FEM IM NAIL 14MMDX36CM FEM IM NAIL 15MMDX36CM FEM IM NAIL 14MMDX38CM FEM IM NAIL 15MMDX38CM FEM IM NAIL 11MMDX40CM FEM IM NAIL 13MMDX40CM FEM IM NAIL 14MMDX40CM FEM IM NAIL 15MMDX40CM FEM IM NAIL 11MMDX42CM FEM IM NAIL 12MMDX42CM FEM IM NAIL 13MMDX42CM FEM IM NAIL 14MMDX42CM FEM IM NAIL 15MMDX42CM FEM IM NAIL 11MMDX44CM FEM IM NAIL 12MMDX44CM FEM IM NAIL 13MMDX44CM FEM IM NAIL 14MMDX44CM FEM IM NAIL 10MMDX46CM FEM IM NAIL 11MMDX46CM FEM IM NAIL 12MMDX46CM FEM IM NAIL 13MMDX46CM FEM IM NAIL 14MMDX46CM FEM IM NAIL 10MMDX48CM FEM IM NAIL 11MMDX48CM FEM IM NAIL 12MMDX48CM FEM IM NAIL 13MMDX48CM FEM IM NAIL 14MMDX48CM FEM IM NAIL 13MMDX50CM FEM IM NAIL 14MMDX50CM

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
Item Numbers: 00225230015 00225230016 00225232014 00225232015 00225232016 00225234014 00225234015 00225234016 0…Item Numbers: 00225230015 00225230016 00225232014 00225232015 00225232016 00225234014 00225234015 00225234016 00225236014 00225236015 00225238014 00225238015 00225240011 00225240013 00225240014 00225240015 00225242011 00225242012 00225242013 00225242014 00225242015 00225244011 00225244012 00225244013 00225244014 00225246010 00225246011 00225246012 00225246013 00225246014 00225248010 00225248011 00225248012 00225248013 00225248014 00225250013 00225250014 Lot Numbers: 60684923 60680624 60680627 60680627R 60680623 60680623R 60680629 60680629R 60680615 60680628 60680615R 60680628R 60680625 60680619 60680619R 60691710 60691708 60691713 60691708R 60732923 60732923R 60691711 60732925 60745751 60691711R 60745751R 60732924 60747393 60747393R 367355 60753357 367355R 60753357R 60721966 60747408 60721966R 367348 60751917 60751917R 60753355 60753356 60758098 60753355R 60715104 60758099 60735584 60735585 60735585R 3

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-2596-2017%22

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