Zimmer, Inc.: Medical Device Recall in 2012 - (Recall #: Z-0212-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

Biolox¿ Option Ceramic Femoral Head System Rx, sterile

Product Classification:

Class II

Date Initiated: September 4, 2012

Date Posted: November 14, 2012

Recall Number: Z-0212-2013

Event ID: 63103

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

Status: Terminated

Product Quantity: 88

Code Information:

REF Numbers: 00-8777-028-02, 00-8777-036-01, 00-8777-036-02, and 00-8777-040-01.

Distribution Pattern:

Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated