FDA Device recall Z-0212-2013
Biolox¿ Option Ceramic Femoral Head System Rx, sterile
- FDA Device
- Class II
- terminated
- Published 2012-11-14
On 2012-11-14 the FDA classified a Class II recall of Biolox¿ Option Ceramic Femoral Head System Rx, sterile by Zimmer, citing 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 recei….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0212-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-09-04 |
| Published | 2012-11-14 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Zimmer |
| Distribution | US |
Product
Biolox¿ Option Ceramic Femoral Head System Rx, sterile
Reason
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
Identifiers
| code_info | REF Numbers: 00-8777-028-02, 00-8777-036-01, 00-8777-036-02, and 00-8777-040-01. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0212-2013%22
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