Recall Z-2595-2017— Zimmer Biomet, Inc.

Name: FDA recall Z-2595-2017
Creator: U.S. Food and Drug Administration
Published: 2017-04-28

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2017-04-28, terminated 2019-05-15. It names one FDA 510(k) clearance: K142281. 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..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-04-28
Terminated: 2019-05-15
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K142281 — ZIMMER M/DN INTRAMEDULLARY FIXATION SYSTEMZimmer, Inc.·cleared 2014-10-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.