PlainRecalls
FDA Devices Moderate Class II Terminated

Biolox¿ Option Ceramic Femoral Head System Rx, sterile

Reported: November 14, 2012 Initiated: September 4, 2012 #Z-0212-2013

Product Description

Biolox¿ Option Ceramic Femoral Head System Rx, sterile

Reason for Recall

Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the info

Details

Recalling Firm
Zimmer, Inc.
Units Affected
88
Distribution
Nationwide Distribution.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
Biolox¿ Option Ceramic Femoral Head System Rx, sterile. Recalled by Zimmer, Inc.. Units affected: 88.
Why was this product recalled?
Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the info
Which agency issued this recall?
This recall was issued by the FDA Devices on November 14, 2012. Severity: Moderate. Recall number: Z-0212-2013.