RecallRadar

FDA Device recall Z-0300-2018

ECHO POR FMRL NC 9X125, model # 192009

On 2018-01-10 the FDA classified a Class II recall of ECHO POR FMRL NC 9X125, model # 192009 by Zimmer Biomet, citing possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label c….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0300-2018
ClassificationClass II
Statusterminated
Initiated2017-06-05
Published2018-01-10
Last updated2026-09-13 11:54 UTC
CompanyZimmer Biomet
DistributionUS

Product

ECHO POR FMRL NC 9X125, model # 192009

Reason

Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.

Identifiers

code_infoLot Number: 410150

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-0300-2018%22

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