PlainRecalls
FDA Devices Moderate Class II Terminated

CER OPTION TYPE 1 TPR SLEVE -6, model # 650-1064

Reported: January 10, 2018 Initiated: June 5, 2017 #Z-0301-2018

Product Description

CER OPTION TYPE 1 TPR SLEVE -6, model # 650-1064

Reason for Recall

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.

Details

Recalling Firm
Zimmer Biomet, Inc.
Units Affected
N/A
Distribution
Nationwide in US; Internationally Argentina, Netherlands & Canada
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
CER OPTION TYPE 1 TPR SLEVE -6, model # 650-1064. Recalled by Zimmer Biomet, Inc.. Units affected: N/A.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 10, 2018. Severity: Moderate. Recall number: Z-0301-2018.